Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
Running, not enrolling · Phase 2
Conditions studied: Stage IV Prostate Adenocarcinoma AJCC v7
In brief
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.
Key facts
- Study ID
- NCT03456843
- Run by
- Yale University
- People needed
- 190
- Starts
- 2018-03-20
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Refuses to give informed consent
- Deemed to have unresectable disease by surgeon
- Received ADT for more than 6 months prior to consent
- Life expectancy of less than 6 months prior to consent
- Active spinal cord compression
- 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
Where it is running
- City of Hope — Duarte, California, United States
- University of California, Irvine — Irvine, California, United States
- University of Southern California — Los Angeles, California, United States
- Yale University — New Haven, Connecticut, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Swedish Medical Services — Seattle, Washington, United States
- Epworth Healthcare — East Melbourne, Australia, Australia
- Chinese University of Hong Kong — Hong Kong, China
- Kindai University — Ōsaka-sayama, Osaka, Japan
- Akita University — Akita, Japan
- Juntendo University — Tokyo, Japan
- National Cancer Center — Goyang-si, South Korea
- Seoul National University Bundang Hospital — Gyeonggi-do, South Korea
- Samsung Medical Center — Seoul, South Korea
- National Taiwan University Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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