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

NCT07234981 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

PSMA-guided Salvage Radiation

External beam radiation therapy will consist of 45 Gy delivered in 25 daily fractions, followed by a sequential boost to PET-avid disease to 63-70.2 Gy in an additional 10-14 fractions.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Michael Baine, PhD/MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-09-05
Completion
2029-10-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234981 on ClinicalTrials.gov