NCT06105918Active, not recruitingPhase 1
Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer
Phase 1 Trial to Determine Safety and Feasibility in Treating Biochemical Recurrence Post-Prostatectomy With PSMA PET Guided External Beam Radiotherapy Followed by Consolidative Radioligand Therapy
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 \[177Lu-rhPSMA-10.1\]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 10 Oct 2023
- Start date
- 29 Nov 2023
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Emory University
- Diseases
- Prostate cancer
- NCT number
- NCT06105918
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 6
- From 29 Nov 2023 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy or prior RLT)
- Definitive findings of systemic metastasis prior imaging (if obtained) or biopsy (if obtained)
- Unacceptable medical or radiation safety risk
Other illness
- Severe acute co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
Lab values
- Risk factors for Lu-rhPSMA radioligand therapy (Baseline \>= grade 2 myelosuppression, renal insufficiency \[glomerular filtration rate (GFR) \< 60 mL/min\], or xerostomia)
- GFR \< 60 mL/min or creatinine \> 1.5-fold upper limit of normal (ULN)
- Liver enzymes \> 5-fold ULN
- Total white cell count less than 2.5 x 10\^9 /L
- Platelet count less than 75 x 10\^9 /L
Other
- Unmanageable urinary tract obstruction or hydronephrosis; patients with diagnosed or who are at high risk of urinary retention
- Any baseline grade 2 or above myelosuppression, nephrotoxicity, hepatotoxicity, xerostomia, or gastrointestinal (GI) toxicity
Who the study is looking for
- Adenocarcinoma of the prostate, post radical prostatectomy with detectable prostate specific antigen (PSA)
- Clinical PSMA PET/CT obtained, with findings of pelvic uptake only (prostate bed, pelvic lymph node uptake, or both)
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
- Age over 18
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.