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Taking people in United StatesPhase 3

Tests timing of lutetium-177 PSMA treatment in advanced prostate cancer

Tests whether delaying later lutetium-177 PSMA doses in men with prostate cancer is workable.

Key facts

Who runs it
Alliance for Clinical Trials in Oncology
Where
Ames, Anaconda, Anchorage, Ankeny, Ann Arbor, Aurora, Bakersfield, Baltimore, Basking Ridge, Battle Creek, Bel Air, Billings, Bismarck, Boone, Bozeman, Brownstown, Buffalo, Burnsville, Cambridge, Cape May Court House, Carroll, Cheyenne, Chicago, Cleveland, Clinton Township, Clive, Cody, Coeur d'Alene, Colorado Springs, Columbia, Commack, Coon Rapids, Dearborn, Decatur, DeKalb, Des Moines, Detroit, Easton, Edina, Edmonds, Egg Harbor, Fargo, Fort Dodge, Geneva, Glen Burnie, Grand Rapids, Great Falls, Harrison, Havre, Helena, Irvine, Jackson, Jefferson, Kalamazoo, Kalispell, La Jolla, Los Angeles, Lubbock, Madison, Maple Grove, Maplewood, Marshalltown, Menomonee Falls, Middletown, Milwaukee, Minneapolis, Missoula, Montvale, Mount Vernon, New Berlin, New Richmond, New Ulm, New York, Newark, Newnan, Niles, Novi, O'Fallon, Oak Brook, Oak Creek, Oklahoma City, Orange, Orland Park, Pella, Pennington, Pontiac, Portland, Post Falls, Princeton, Reed City, Richmond, Robbinsdale, Sacramento, Saint Cloud, Saint Joseph, Saint Louis Park, Saint Paul, San Diego, Sandpoint, Seattle, Shakopee, Sioux Falls, St Louis, Stillwater, The Bronx, Traverse City, Uniondale, Waconia, Warrenville, Waukee, West Bend, West Bloomfield, West Des Moines, Willmar, Woodbury, Wyandotte, Wyoming, and Zion, United StatesSee the 142 sites
Trial code
Registry title
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Status
Recruiting
Phase
Phase 3
People taking part
1,524 people, planned
Started
31 Mar 2026
Expected to end
9 Sept 2034
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Lutetium Lu 177 Vipivotide Tetraxetan
  • Biospecimen Collection
  • Patient Monitoring
  • Computed Tomography
  • Bone Scan
  • PSMA PET Scan
  • MRI
  • Questionnaire Administration
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with advanced prostate cancer that has stopped responding to hormone treatment and shows PSMA on a scan. It tests a longer gap between doses of lutetium 177 Lu PSMA RLT.

Age
18 years or older
Sex
Men only
Disease stage
Prostate adenocarcinoma that is metastatic, castration-resistant and getting worse, with a positive PSMA PET/CT scan and PSA greater than 2.0 ng/mL
Earlier treatment
Must have had at least one androgen receptor pathway inhibitor (apalutamide, darolutamide, enzalutamide or abiraterone), stopped at least 4 weeks before. Must have had orchiectomy or ongoing androgen-deprivation therapy. Must not have had taxane chemotherapy for mCRPC. Must not have had PSMA-targeted radioligand therapy.
Biomarker or test result
Positive PSMA PET/CT scan (uptake greater than liver). Castrate testosterone level (< 50 ng/dL or < 1.7 nmol/L). After 2 doses, PSA decline of ≥ 50%.

Main reasons for not taking part

  • Previous PSMA-targeted radioligand therapy
  • Any systemic anti-cancer therapy within 28 days before pre-registration
  • Strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223 or hemi-body irradiation within 6 months
  • Symptomatic or impending spinal cord compression
  • Acute biliary or urinary obstruction

The registry criteria, word for word

Show all 35 criteriaShow less

Who can take part

  • PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and/or cytological confirmation of prostate adenocarcinoma
  • PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET/CT scan (either gallium Ga 68 gozetotide [68Ga-PSMA-11], fluorine F 18 piflufolastat [18F- DCFPyl], or fluorine F 18 flotufolastat gallium [18F-rhPSMA-7.3]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease
  • PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng/mL
  • PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:; Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL; Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions; Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 [PCWG3] criteria, Scher et al 2016)
  • PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
  • PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone); ARPI must be stopped at least 4 weeks prior to pre-registration
  • PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration
  • PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.)
  • PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible
  • PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed
  • PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to pre-registration is not allowed
  • PRE-REGISTRATION (STEP 0): Age ≥ 18 years
  • PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
  • PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000/mm\^3
  • PRE-REGISTRATION (STEP 0): Total bilirubin < 1.5 x upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's syndrome
  • PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation
  • PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction
  • PRE-REGISTRATION (STEP 0): Patients with treated/stable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression; Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)
  • PRE-REGISTRATION (STEP 0): Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
  • PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • PRE-REGISTRATION (STEP 0): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • PRE-REGISTRATION (STEP 0): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
  • PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration
  • PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
  • PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs
  • PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration
  • PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
  • PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish
  • REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT
  • REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +/-3 days
  • REGISTRATION (STEP 1): ECOG Performance Status ≤ 2
  • REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
  • REGISTRATION (STEP 1): Platelet count ≥ 100,000/mm\^3
  • REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation

Where in United States

  • Mary Greeley Medical CenterAmes, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • McFarland Clinic - AmesAmes, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • Community Hospital of AnacondaAnaconda, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Providence Alaska Medical CenterAnchorage, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesContact: Samir Narayan (principal investigator)Taking people
  • UCHealth University of Colorado HospitalAurora, United StatesContact: Elizabeth R. Kessler (principal investigator)Taking people
  • AIS Cancer Center at San Joaquin Community HospitalBakersfield, United StatesContact: Luis Mariscal (principal investigator)Taking people
  • Maryland Proton Treatment CenterBaltimore, United StatesContact: Zaker H. Rana (principal investigator)Taking people
  • University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesContact: Zaker H. Rana (principal investigator)Taking people
  • Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesContact: Deaglan McHugh (principal investigator)Taking people
  • Bronson Battle CreekBattle Creek, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • UM Upper Chesapeake Medical CenterBel Air, United StatesContact: Zaker H. Rana (principal investigator)Taking people
  • Billings Clinic Cancer CenterBillings, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Sanford Bismarck Medical CenterBismarck, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • McFarland Clinic - BooneBoone, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Bozeman Health Deaconess HospitalBozeman, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Henry Ford Cancer Institute-DownriverBrownstown, United StatesContact: Clara Hwang (principal investigator)Taking people
  • Roswell Park Cancer InstituteBuffalo, United StatesContact: Ellis G. Levine (principal investigator)Taking people
  • Minnesota Oncology - BurnsvilleBurnsville, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Cambridge Medical CenterCambridge, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • AtlantiCare Health Park-Cape May Court HouseCape May Court House, United StatesContact: James C. Wurzer (principal investigator)Taking people
  • Saint Anthony Regional HospitalCarroll, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Memorial Hospital of Laramie CountyCheyenne, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Northwestern UniversityChicago, United StatesContact: Michael Liu (principal investigator)Taking people
  • MetroHealth Medical CenterCleveland, United StatesContact: Joseph Attallah (principal investigator)Taking people
  • Henry Ford Macomb Hospital-Clinton TownshipClinton Township, United StatesContact: Clara Hwang (principal investigator)Taking people
  • UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Billings Clinic-CodyCody, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Memorial Hospital NorthColorado Springs, United StatesContact: Elizabeth R. Kessler (principal investigator)Taking people
  • UCHealth Memorial Hospital CentralColorado Springs, United StatesContact: Elizabeth R. Kessler (principal investigator)Taking people
  • Central Maryland Radiation Oncology in Howard CountyColumbia, United StatesContact: Zaker H. Rana (principal investigator)Taking people
  • Memorial Sloan Kettering CommackCommack, United StatesContact: Deaglan McHugh (principal investigator)Taking people
  • Mercy HospitalCoon Rapids, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Henry Ford Medical Center-FairlaneDearborn, United StatesContact: Clara Hwang (principal investigator)Taking people
  • Cancer Care Specialists of Illinois - DecaturDecatur, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Decatur Memorial HospitalDecatur, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesContact: Michael Liu (principal investigator)Taking people
  • Iowa Methodist Medical CenterDes Moines, United StatesContact: Seema Harichand-Herdt (principal investigator)Taking people
  • Broadlawns Medical CenterDes Moines, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Henry Ford HospitalDetroit, United StatesContact: Clara Hwang (principal investigator)Taking people
  • University of Maryland Shore Medical Center at EastonEaston, United StatesContact: Zaker H. Rana (principal investigator)Taking people
  • Fairview Southdale HospitalEdina, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Swedish Cancer Institute-EdmondsEdmonds, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • AtlantiCare Surgery CenterEgg Harbor, United StatesContact: James C. Wurzer (principal investigator)Taking people
  • Sanford Broadway Medical CenterFargo, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Sanford Roger Maris Cancer CenterFargo, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • UI Healthcare Mission Cancer and Blood - Fort DodgeFort Dodge, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Northwestern Medicine Cancer Center DelnorGeneva, United StatesContact: Michael Liu (principal investigator)Taking people
  • UM Baltimore Washington Medical Center/Tate Cancer CenterGlen Burnie, United StatesContact: Zaker H. Rana (principal investigator)Taking people
  • Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Benefis Sletten Cancer InstituteGreat Falls, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Great Falls ClinicGreat Falls, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Memorial Sloan Kettering WestchesterHarrison, United StatesContact: Deaglan McHugh (principal investigator)Taking people
  • Hi-Line Sletten Cancer CenterHavre, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Benefis Helena Specialty CenterHelena, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • City of Hope at Irvine LennarIrvine, United StatesContact: Charles B. Nguyen (principal investigator)Taking people
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United StatesContact: Omid Yazdanpanah (principal investigator)Taking people
  • Allegiance HealthJackson, United StatesContact: Clara Hwang (principal investigator)Taking people
  • McFarland Clinic - JeffersonJefferson, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Bronson Methodist HospitalKalamazoo, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • West Michigan Cancer CenterKalamazoo, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Logan Health Medical CenterKalispell, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesContact: Yu-Wei Chen (principal investigator)Taking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Edwin M. Posadas (principal investigator)Taking people
  • Covenant Medical Center-LakesideLubbock, United StatesContact: Gabriel Axelrud (principal investigator)Taking people
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United StatesContact: John M. Floberg (principal investigator)Taking people
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesContact: John M. Floberg (principal investigator)Taking people
  • Fairview Clinics and Surgery Center Maple GroveMaple Grove, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Minnesota Oncology Hematology PA-MaplewoodMaplewood, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Saint John's Hospital - HealtheastMaplewood, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • McFarland Clinic - MarshalltownMarshalltown, United StatesContact: Joseph J. Merchant (principal investigator)Taking people
  • Froedtert Menomonee Falls HospitalMenomonee Falls, United StatesContact: Kathryn A. Bylow (principal investigator)Taking people
  • Memorial Sloan Kettering MonmouthMiddletown, United StatesContact: Deaglan McHugh (principal investigator)Taking people
  • Medical College of WisconsinMilwaukee, United StatesContact: Kathryn A. Bylow (principal investigator)Taking people
  • Abbott-Northwestern HospitalMinneapolis, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Hennepin County Medical CenterMinneapolis, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Community Medical CenterMissoula, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Memorial Sloan Kettering BergenMontvale, United StatesContact: Deaglan McHugh (principal investigator)Taking people
  • SSM Health Good SamaritanMount Vernon, United StatesContact: Jay W. Carlson (principal investigator)Taking people
  • Froedtert and MCW Moorland Reserve Health CenterNew Berlin, United StatesContact: Kathryn A. Bylow (principal investigator)Taking people
  • Cancer Center of Western WisconsinNew Richmond, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • New Ulm Medical CenterNew Ulm, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesContact: Deaglan McHugh (principal investigator)Taking people
  • Helen F Graham Cancer CenterNewark, United StatesContact: Gregory A. Masters (principal investigator)Taking people
  • Medical Oncology Hematology Consultants PANewark, United StatesContact: Gregory A. Masters (principal investigator)Taking people
  • CTCA at Southeastern Regional Medical CenterNewnan, United StatesContact: Bamidele A. Adesunloye (principal investigator)Taking people
  • Corewell Health Lakeland Hospitals - Niles HospitalNiles, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Henry Ford Medical Center-ColumbusNovi, United StatesContact: Clara Hwang (principal investigator)Taking people
  • Cancer Care Center of O'FallonO'Fallon, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • HSHS Saint Elizabeth's HospitalO'Fallon, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Northwestern Medicine Oak BrookOak Brook, United StatesContact: Michael Liu (principal investigator)Taking people
  • Drexel Town Square Health CenterOak Creek, United StatesContact: Kathryn A. Bylow (principal investigator)Taking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesContact: Tyler Gunter (principal investigator)Taking people
  • UC Irvine Health- Chao Family Comprehensive Cancer CenterOrange, United StatesContact: Omid Yazdanpanah (principal investigator)Taking people
  • Northwestern Medicine Orland ParkOrland Park, United StatesContact: Michael Liu (principal investigator)Taking people
  • UI Healthcare Mission Cancer and Blood - PellaPella, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Capital Health Medical Center-HopewellPennington, United StatesContact: Nikhil Thaker (principal investigator)Taking people
  • Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesContact: Samir Narayan (principal investigator)Taking people
  • Providence Portland Medical CenterPortland, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • Providence Saint Vincent Medical CenterPortland, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Fairview Northland Medical CenterPrinceton, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Corewell Health Reed City HospitalReed City, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • VCU Massey Comprehensive Cancer CenterRichmond, United StatesContact: John Melson (principal investigator)Taking people
  • North Memorial Medical Health CenterRobbinsdale, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • University of California Davis Comprehensive Cancer CenterSacramento, United StatesContact: Lorenzo Nardo (principal investigator)Taking people
  • Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United StatesContact: Donald J. Jurgens (principal investigator)Taking people
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Heartland Regional Medical CenterSaint Joseph, United StatesContact: Jay W. Carlson (principal investigator)Taking people
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • United HospitalSaint Paul, United StatesContact: Yan Ji (principal investigator)Taking people
  • Regions HospitalSaint Paul, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • UC San Diego Medical Center - HillcrestSan Diego, United StatesContact: Yu-Wei Chen (principal investigator)Taking people
  • Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesContact: John M. Schallenkamp (principal investigator)Taking people
  • Swedish Medical Center-First HillSeattle, United StatesContact: Alison K. Conlin (principal investigator)Taking people
  • Saint Francis Regional Medical CenterShakopee, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Sanford Cancer Center Oncology ClinicSioux Falls, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesContact: Daniel Almquist (principal investigator)Taking people
  • Missouri Baptist Medical CenterSt Louis, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Lakeview HospitalStillwater, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Montefiore Medical Center - Moses CampusThe Bronx, United StatesContact: Benjamin A. Gartrell (principal investigator)Taking people
  • Montefiore Medical Center-Einstein CampusThe Bronx, United StatesContact: Benjamin A. Gartrell (principal investigator)Taking people
  • Munson Medical CenterTraverse City, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Memorial Sloan Kettering NassauUniondale, United StatesContact: Deaglan McHugh (principal investigator)Taking people
  • Ridgeview Medical CenterWaconia, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesContact: Michael Liu (principal investigator)Taking people
  • UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Froedtert West Bend Hospital/Kraemer Cancer CenterWest Bend, United StatesContact: Kathryn A. Bylow (principal investigator)Taking people
  • Henry Ford West Bloomfield HospitalWest Bloomfield, United StatesContact: Clara Hwang (principal investigator)Taking people
  • The Iowa Clinic PCWest Des Moines, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Rice Memorial HospitalWillmar, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Minnesota Oncology Hematology PA-WoodburyWoodbury, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Henry Ford Wyandotte HospitalWyandotte, United StatesContact: Clara Hwang (principal investigator)Taking people
  • University of Michigan Health - WestWyoming, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Fairview Lakes Medical CenterWyoming, United StatesContact: Shiva Baghaie, MPHNo longer taking part
  • Midwestern Regional Medical CenterZion, United StatesContact: Walter M. Stadler (principal investigator)Taking people

About the trial

What the trial wants to find out

This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.

The 3 groups in the trial

  • Pre-registration step 0 (177Lu PSMA RLT)Existing treatment, for comparison

    Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PSA50 response at C2 D22 proceed to Step 1. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial.

    Treatment: Lutetium Lu 177 Vipivotide Tetraxetan, Biospecimen Collection, Computed Tomography, Bone Scan, PSMA PET Scan, MRI, and Questionnaire Administration

  • Randomization step 1 arm 1 (standard dose 177Lu PSMA RLT)Existing treatment, for comparison

    Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial

    Treatment: Lutetium Lu 177 Vipivotide Tetraxetan, Biospecimen Collection, Computed Tomography, Bone Scan, PSMA PET Scan, MRI, and Questionnaire Administration

  • Randomization step 1 arm 2 (adaptive dose 177Lu PSMA RLT )Treatment being tested

    Starting cycle 2 day 42, patients undergo blood sample collection and PSA monitoring Q3W in the absence of disease progression or unacceptable toxicity. Patients with either an absolute PSA rise \> 4 ng/dL, PSA rise \> 25% above nadir, or clinical progression receive 177Lu PSMA RLT IV three weeks later. Patients then resume PSA monitoring Q3W with adaptive 177Lu PSMA RLT dosing as above for up to 4 total doses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial.

    Treatment: Lutetium Lu 177 Vipivotide Tetraxetan, Biospecimen Collection, Patient Monitoring, Computed Tomography, Bone Scan, PSMA PET Scan, MRI, and Questionnaire Administration

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)
Plain-language title
Tests timing of lutetium-177 PSMA treatment in advanced prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026