Surgical removal of the prostate combined with antiandrogen therapy for 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
This study is testing if combining surgery to remove the prostate with antiandrogen therapy helps men with newly diagnosed metastatic prostate cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 20 sites (Duarte, California and 19 other locations) |
| Trial ID | NCT03456843 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of cytoreductive radical prostatectomy combined with the best systemic therapy in men with newly diagnosed metastatic prostate cancer. Participants are randomized into two groups: one receiving antiandrogen therapy with or without docetaxel, and the other undergoing surgery after a month of antiandrogen therapy. The study aims to evaluate clinical benefits, time to biochemical progression, cancer-specific survival, complication rates, and quality of life. Additionally, it will analyze specific biomarker levels related to cancer progression.
Who should consider this trial
Good fit: Ideal candidates include men with histologically confirmed metastatic prostate adenocarcinoma who have not received prior local therapy and are deemed suitable for surgery.
Not a fit: Patients with non-resectable prostate cancer or those who have previously undergone local therapy for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for men with metastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar surgical and systemic therapy combinations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 antiandrogen therapy (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 Exclusion Criteria: * 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 this trial is running
Duarte, California and 19 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- University of California — Irvine, California, United States (Withdrawn)
- University of Southern California — Los Angeles, California, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Withdrawn)
- University of Louisville — Louisville, Kentucky, United States (Withdrawn)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- Unniversity of Pennsylvania — Philadelphia, Pennsylvania, United States (Terminated)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Withdrawn)
- Swedish Medical Services — Seattle, Washington, United States (Recruiting)
- Epworth Healthcare — East Melbourne, Australia (Active_not_recruiting)
- Chinese University of Hong Kong — Hong Kong, China (Recruiting)
- Kyoto University — Sako, Kyoto, Japan (Withdrawn)
- Kindai University — Ōsaka-sayama, Osaka, Japan (Recruiting)
- Akita University — Akita, Japan (Recruiting)
- Juntendo University — Tokyo, Japan (Recruiting)
- National Cancer Center — Goyang-si, Korea, Republic of (Recruiting)
- Seoul National University Bundang Hospital — Gyeonggi-do, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Isaac Kim — Yale University
- Study coordinator: Stephanie Ladd
- Email: ycciprojectmanagement@yale.edu
- Phone: (203) 785-3482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.