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PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 11 words Secondary endpoints: details revised at 1 of 4 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Notable Recruitment opened Primary completion pushed from Aug 5, 2029 to Sep 5, 2029 · Completion pushed from Aug 5, 2029 to Oct 5, 2029 · Start date changed from estimate of Mar 5, 2026 to Mar 31, 2026 · 2 morev4 Show 5 more changesShow less
    • Primary completion pushed from Aug 5, 2029 to Sep 5, 2029
    • Completion pushed from Aug 5, 2029 to Oct 5, 2029
    • Start date changed from estimate of Mar 5, 2026 to Mar 31, 2026
    • Site details revised
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Start date: Jan 5, 2026 to Mar 5, 2026 Primary and study completion dates: Jun 5, 2029 to Aug 5, 2029v3 Show 1 more changeShow less
    • Primary and study completion dates: Jun 5, 2029 to Aug 5, 2029
  4. Minor Secondary endpoints: details revised at 1 of 4 entriesv2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Purpose: Prospective, single-site Phase II study testing whether PSMA-PET/MRI-guided, de-escalated salvage radiation reduces acute Grade ≥2 toxicity versus a 44% historical rate, while maintaining cancer control after prostatectomy.Population/Eligibility: Adult men ≥30 years with prior radical prostatectomy and biochemical persistence/recurrence per NCCN (persistent positive PSA after RP, or undetectable PSA that becomes detectable and rises on ≥2 determinations, or PSA \>0.1 ng/mL). Must have a targetable PSMA-avid lesion in the prostate bed and/or pelvic lymph nodes and/or an MRI-defined lesion suspicious for local recurrence. KPS ≥80 or ECOG ≤2; life expectancy \>5 years; able to consent. Exclude: Evidence of distant metastatic disease outside pelvic nodes (including osseous involvement), conditions that preclude radiation, or factors preventing protocol compliance.Interventions \& Evaluations: Baseline history/physical, vitals, performance status, labs (PSA, CBC w/diff, CMP/creatinine), pelvic MRI and PSMA-PET/CT; optional biopsy if feasible. External beam radiation therapy (LINAC/VMAT) with daily image guidance: pelvis 45 Gy in 25 fractions, followed by a sequential boost to PSMA/MRI-defined disease to 63-70.2 Gy in 10-14 additional fractions, with protocolized OAR constraints. All participants receive standard-of-care androgen deprivation therapy (ADT) for 6-24 months at the treating clinician's discretion. Weekly on-treatment visits; physician-assessed toxicities graded by CTCAE v5. Patient-reported outcomes (IPSS; FACT-P) at baseline and each in-person follow-up.Follow-up: Phone toxicity check 1 month post-RT; clinic at 4 months post-RT, then every 3 months thereafter until 24 months after completion of ADT. At each visit: H\&P, CTCAE toxicity assessment, and PSA. If biochemical failure occurs, imaging (PSMA-PET/CT, CT and/or MRI) is obtained per standard of care to assess clinical progression.Endpoints/Design: Primary endpoint: acute (≤4 months post-RT) Grade ≥2 toxicity (all types). Secondary endpoints: 2-year biochemical progression-free survival; chronic toxicity and patient-reported outcomes from 4-24 months; 24-month local control, locoregional control, distant metastasis, and overall survival. Simon optimal two-stage design with interim analysis after the first 18 patients complete RT (stop if ≥8 have Grade ≥2 acute toxicity); total planned enrollment up to 54.
Trial Details
NCT Number NCT07234981
Lead Sponsor University of Nebraska
Conditions Prostate Cancer
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov