🏛️ Verified NIH Record • Updated 2026-07-22

Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer (NCT03456843)

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

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Yale University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: City of Hope — Duarte, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (16 Sites)

  • City of Hope — Duarte, California
  • University of California, Irvine — Irvine, California
  • University of Southern California — Los Angeles, California
  • Yale University — New Haven, Connecticut
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
  • University of Pennsylvania — Philadelphia, Pennsylvania
  • Swedish Medical Services — Seattle, Washington
  • Epworth Healthcare — East Melbourne, Australia
  • Chinese University of Hong Kong — Hong Kong,
  • Kindai University — Ōsaka-sayama, Osaka
  • Akita University — Akita,
  • Juntendo University — Tokyo,
  • National Cancer Center — Goyang-si,
  • Seoul National University Bundang Hospital — Gyeonggi-do,
  • Samsung Medical Center — Seoul,
  • National Taiwan University Hospital — Taipei,

📞 Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗