PSMA PET-Guided Progression-Directed Radiotherapy for Oligoprogressive Prostate Cancer

Sponsor
Affidea Nu-med Center of Oncological DIagnostics and Therapy
Study ID
NCT07691697
Status
Recruiting
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Conditions

  • Metastatic Prostate Cancer
  • Oligoprogressive Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Progression-Directed Radiotherapy — RADIATION
    Progression-directed radiotherapy delivered with ablative or definitive local intent to all identifiable PSMA PET-defined oligoprogressive lesions as part of routine clinical care. Treatment may include stereotactic body radiotherapy, moderately hypofractionated external beam radiotherapy, brachytherapy for intraprostatic or prostate-bed recurrence, or brachytherapy for selected metastatic lesions when clinically appropriate.

Study Details

PSMA-OLIGO-PRO is a multicenter ambispective observational real-world registry evaluating outcomes after PSMA PET-guided progression-directed radiotherapy for oligoprogressive prostate cancer. The registry includes retrospectively identified patients treated before June 26, 2026 and prospectively enrolled patients from June 26, 2026 onward. Eligible patients have metastatic hormone-sensitive or castration-resistant prostate cancer, are receiving active systemic therapy, and develop a limited number of new or regrowing lesions while the remaining disease sites are controlled. Oligoprogression is primarily defined by PSMA PET/CT or PSMA PET/MR, with MRI used when clinically appropriate, particularly for intraprostatic, local, or prostate-bed progression. Participants are not assigned to treatment by the registry protocol. All imaging, systemic therapy, radiotherapy modality, dose, fractionation, and follow-up decisions are made by treating physicians as part of routine clinical care. Progression-directed radiotherapy may include stereotactic body radiotherapy for nodal, bone, visceral, or local lesions, moderately hypofractionated external beam radiotherapy when clinically selected, and brachytherapy when appropriate for intraprostatic, prostate-bed, or selected metastatic oligoprogressive lesions. The registry evaluates whether treating all identifiable oligoprogressive lesions can delay escalation to a new systemic therapy line, preserve the oligometastatic state, maintain local control, and provide acceptable safety in contemporary PSMA PET-guided practice.

Key Dates

First listed
Jul 9, 2026
Start date
Jun 26, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2030
Completion
Dec 30, 2031

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: PSMA PET-Guided PDRT Registry Cohort
    Single observational cohort of patients with metastatic hormone-sensitive or castration-resistant prostate cancer who develop PSMA PET-defined oligoprogression during active systemic therapy and undergo progression-directed radiotherapy in routine clinical practice. Patients may contribute retrospective data, retrospective data with prospective follow-up updates, or fully prospective data, depending on treatment and enrollment timing.

Primary Outcome Measure

Time to Next Systemic Therapy Escalation [ Time Frame: From start of index progression-directed radiotherapy to initiation of a new systemic therapy line, assessed up to 5 years ]

Central Contacts

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