Sign in

NCT03456843Active, not recruitingPhase 2

Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate Cancer

Source: ClinicalTrials.gov · Last updated 24 Jul 2026

Brief summary (registry, in English)

This is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Such hybrid design permits the inclusion of the patients who have accrued to the phase 2 investigation to phase 3 trial, thereby decreasing the number of patients needed overall (5-7). In the initial phase 2 study, we plan to accrue 190 patients.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
190 (estimated)
First submitted
20 Feb 2018
Start date
20 Mar 2018
Primary completion date
31 Mar 2027
Lead sponsor
Yale University
NCT number
NCT03456843

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 190
  • From 20 Mar 2018 to the primary completion date, 31 Mar 2027
  • 16 sites in 6 countries
  • 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

  • Received ADT for more than 6 months prior to consent
  • Life expectancy of less than 6 months prior to consent
  • Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent
  • Previous local therapy for prostate cancer
  • Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

Other illness

  • Deemed to have unresectable disease by surgeon

Other

  • Refuses to give informed consent
  • Active spinal cord compression

Who the study is looking for

  • Histologically proven adenocarcinoma of the prostate
  • Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
  • Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.
  • If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician)
  • No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)
  • Give informed consent
  • Prostate deemed resectable by surgeon
  • Plans to start or has already started ADT no longer than 6 months prior to consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Hemoglobin (HgB) \>= 9 g/dL compatible for surgery
  • Platelets \> 80,000/mcL compatible for surgery
  • Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery
  • Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Epworth Healthcare
Coordinator of this site? Confirm its status
East MelbourneAustraliaUnknown status
Chinese University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongChinaUnknown status
Akita University
Coordinator of this site? Confirm its status
AkitaJapanUnknown status
Kindai University
Coordinator of this site? Confirm its status
Ōsaka-sayamaJapanUnknown status
Juntendo University
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
National Cancer Center
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaUnknown status
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
Gyeonggi-doSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
City of Hope
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
University of California, Irvine
Coordinator of this site? Confirm its status
IrvineUnited StatesUnknown status
University of Southern California
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Yale University
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Swedish Medical Services
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.