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
- Diseases
- Prostate cancer
- 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
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Epworth Healthcare Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
| Akita University Coordinator of this site? Confirm its status | Akita | Japan | Unknown status |
| Kindai University Coordinator of this site? Confirm its status | Ōsaka-sayama | Japan | Unknown status |
| Juntendo University Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Swedish Medical Services Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.