PSMA-PET/MRI guided lower-dose salvage radiation for recurrent prostate cancer

PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Patients With Recurrent Prostate Cancer After Prostatectomy

This trial tests whether using PSMA-PET/MRI to guide lower-dose salvage radiation can reduce short-term side effects while still controlling cancer in men with rising PSA after prostate removal.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 30 Years and up
• Sex: Male
• Sponsor: University of Nebraska (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT07234981 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-site Phase II study using PSMA-PET/MRI to target and de-escalate salvage radiation after radical prostatectomy. Men with biochemical persistence or recurrence and a PSMA-avid or MRI-suspicious lesion in the prostate bed or pelvic nodes receive PSMA-guided, reduced-intensity radiation. The primary comparison is acute Grade ≥2 toxicity versus a 44% historical rate, with cancer control monitored after treatment. Key eligibility includes age ≥30, KPS ≥80/ECOG ≤2, life expectancy >5 years, and no distant metastases outside the pelvis.

Who should consider this trial

Good fit: Adult men (≥30 years) after radical prostatectomy with biochemical recurrence and a targetable PSMA-avid or MRI-defined lesion in the prostate bed or pelvic nodes, good performance status (KPS ≥80 or ECOG ≤2), and life expectancy >5 years.

Not a fit: Patients with distant metastatic disease outside the pelvic nodes, those who cannot safely receive radiation, or those without targetable PSMA/MRI lesions are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could lower moderate-to-severe acute radiation side effects while preserving post-prostatectomy cancer control.

How similar studies have performed: PSMA-PET has improved lesion detection and has been used to guide targeted radiation in prior studies, but prospectively testing de-escalation to reduce toxicity while maintaining control remains relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Prior biopsy proven prostate cancer for which they underwent a radical prostatectomy with curative intent.
2. Evidence of biochemical recurrence as defined by NCCN: Persistent positive PSA post-radical prostatectomy (RP) or an undetectable PSA after RP with a subsequent detectable PSA that increases on ≥2 determinations (PSA recurrence) or increases to PSA \>0.1 ng/mL.
3. Targetable PSMA-avid lesion within the prostate bed, pelvic lymph nodes, or both and/or targetable lesion in prostate bed defined on MRI suspicious for local recurrence.
4. If lesions are amenable for biopsy this may be attempted, but biopsy proven recurrence/persistence is not required for trial enrollment.
5. Life expectancy greater than 5 years.
6. Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group performance status ≤ 2 within 14 days prior to registration.
7. Age ≥ 30 years.
8. Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

1. Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease).
2. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
3. Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include but are not limited to inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy.

Where this trial is running

Omaha, Nebraska

• University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)

Study contacts

• Principal investigator: Michael Baine, PhD/MD — University of Nebraska
• Study coordinator: Taylor Johnson

Conditions Prostate Cancer