PSMA PET-Guided Progression-Directed Radiotherapy for Oligoprogressive Prostate Cancer
Recruiting · NCT07691697 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age 18 years or older.
- Diagnosis of prostate cancer.
- Metastatic hormone-sensitive prostate cancer or metastatic castration-resistant prostate cancer.
- Receiving active systemic therapy at the time of oligoprogression.
- Oligoprogression defined as up to five new and/or regrowing lesions detected on PSMA PET/CT or PSMA PET/MR, with other known disease sites remaining controlled.
- Planned or completed PSMA PET-guided progression-directed radiotherapy to all clinically relevant oligoprogressive lesions as part of routine clinical care.
- Radiotherapy may include stereotactic body radiotherapy, moderately hypofractionated external beam radiotherapy, brachytherapy, combined external beam radiotherapy and brachytherapy, or mixed-modality radiotherapy, when clinically appropriate.
- Availability of baseline clinical, imaging, treatment, and follow-up data sufficient for registry endpoints.
Exclusion criteria
- Polymetastatic progression not consistent with an oligoprogressive state at the time of index radiotherapy.
- More than five new or regrowing lesions at the index oligoprogression episode.
- Radiotherapy delivered with purely palliative symptom-control intent rather than progression-directed local control intent.
- Lack of sufficient clinical, imaging, treatment, or follow-up information for endpoint assessment.
- Any condition that, in the opinion of the treating physician or investigator, makes registry inclusion inappropriate.
Where it is running
1 location listed.
- Affidea Nu-Med Cancer Diagnostics and Therapy Center - Zamość, Lublin Voivodeship, Poland