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Management of Castration-Resistant Prostate Cancer with Oligometastases

Study acronym: PCS IX
StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary completion date: Apr 2025 to Apr 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 130 to confirmed 102
    • Site details revised at 11 of 11 sites
    v8
  2. Site contacts updated at 1 of 11 sitesv7
  3. Start date: Aug 2016 to Oct 2016
    • Study sites: 1 to 11
    v6
  4. Site contact updatedv5
  5. Eligibility criteria shortened, about 1 wordv4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Aug 2041
    • Site details revised
    v3
  2. Start date: Apr 2016 to Aug 2016v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This adaptive phase II/III randomized trial is designed to demonstrate that eradication of oligometastases by SBRT is a promising and emerging way to delay disease progression and postpone second line systemic therapies in castration-resistant prostate cancer (CRPC) patients. Only CRPC patients with an oligometastatic recurrence will be eligible to take part in this trial. All participating patients will receive either the standard of care (i.e. LHRH agonist in combination with the new generation of hormonal therapy \[Enzalutamide\]) or the experimental treatment (i.e. LHRH agonist in combination with the new generation of HT \[Enzalutamide\] plus the additional SBRT treatment). The patients will undergo different evaluations before treatment, such as imaging to confirm oligometastatic recurrence and blood tests. Patients will be stratified according to the location of metastasis (visceral \[with or without bone metastases\] vs. bone metastases alone) and PSA doubling time (≤ 3 vs. \> 3 months). As per the standard of care, patients will have PSA testing performed every 6-12 weeks and re-imaging at 6, 9, 12, 18 and 24 months or at PSA progression, whichever occurs first.
Trial Details
NCT Number NCT02685397
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Conditions
(from sponsor)		 Castration-resistant Prostate Cancer Patients with Oligometastases
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov