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

NCT07691697 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-07-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

Progression-Directed Radiotherapy

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.

Sponsors & Collaborators

  • Affidea Nu-med Center of Oncological DIagnostics and Therapy

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-26
Primary Completion
2030-12-30
Completion
2031-12-30

Countries

  • Poland

Study Locations

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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 NCT07691697 on ClinicalTrials.gov