🏛️ Verified NIH Record • Updated 2026-05-22

Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) (NCT04070209)

The Role of Therapeutic Layering of Stereotactic Body Radiotherapy on Darolutamide in the Management of Oligoprogressive Castration Resistant Prostate Cancer: A Pilot Phase II Trial

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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

This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (35 items).

Location: Prostate Cancer Centre — Calgary, Alberta

Age range: 18 Years

🧪 Interventions in This Study

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria (Part 1):
  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
  • Presence of distant metastasis, including previously treated (clinical stage M1) is exclusive, however isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion criteria.
  • History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer;
  • Absolute neutrophil count \< 1,500/μL, platelet count \< 100,000/μL, or hemoglobin \< 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit);
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal and total bilirubin \> 1.5 times the upper limit of normal at the Screening visit;
  • Creatinine \> 2 times the upper limit of normal at the Screening visit;
  • Clinically significant cardiovascular disease including:
  • Stroke or myocardial infarction within 6 months;
  • Uncontrolled angina within 6 months;
  • Coronary/peripheral artery bypass graft within 6 months;
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

  • Prostate Cancer Centre — Calgary, Alberta
  • Centre of Applied Urology Research — Halifax, Nova Scotia
  • St. Joseph's Healthcare Hamilton — Hamilton, Ontario
  • Hôpital de Gatineau — Gatineau, Quebec
  • Service d'urologie et Centre de la prostate — Longueuil, Quebec
  • Hôpital Maisonneuve-Rosemont — Montreal, Quebec
  • Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec
  • Sir Mortimer JGH — Montreal, Quebec
  • L'Hôtel-Dieu de Québec (CHUQ) — Québec, Quebec
  • Hôpital Fleurimont (CHUS) — Sherbrooke, Quebec
  • Centre hospitalier affilié universitaire régional (CHAUR) — Trois-Rivières, Quebec

💰 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.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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 ↗