PSMA PET-Staged Progression-Directed Radiotherapy for Limited Prostate Cancer Progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PSMA-OLIGO-PRO is an observational, multicenter, ambispective registry of adults with metastatic prostate cancer who develop a limited number of progressing lesions during ongoing systemic treatment and are considered for targeted radiotherapy guided by PSMA PET findings. The study does not assign treatments or imaging; decisions about PSMA PET, systemic plans, and radiotherapy are made by treating clinicians as part of routine care. It includes retrospective cases treated before mid-2026 and prospective cases enrolled after that date, with defined lesion-count ceilings that evolve over time. Baseline PSMA PET/CT or PSMA PET/MRI is required for each included episode, and different cohorts reflect varying lesion burdens (1-5 lesions, or 6-10 in the post-amendment period).

Why it matters

Who can join: the full rules

* Age 18 years or older.
* Histologically confirmed prostate adenocarcinoma.
* Metastatic hormone-sensitive or metastatic castration-resistant prostate cancer.
* Active systemic anticancer therapy at the qualifying limited-progression assessment.
* Qualifying baseline PSMA PET/CT or PSMA PET/MRI with review of relevant anatomical imaging.
* Metachronous, repeat, or induced oligoprogression or limited progression according to the protocol framework.
* Retrospective cases treated before June 26, 2026: 1-5 qualifying progressing metastatic lesions.
* Prospective cases enrolled before the site-specific amendment effective date: 1-5 qualifying progressing metastatic lesions.
* Prospective cases enrolled after the site-specific amendment effective date: 1-10 qualifying progressing metastatic lesions, prespecified as 1-5 or 6-10.
* Intraprostatic or prostate-bed progressing foci are recorded separately from the metastatic-lesion count and must also be technically amenable to comprehensive PDRT.
* Every qualifying metastatic and local progressing site is judged technically amenable to comprehensive definitive-intent PDRT before prospective analytic-cohort enrollment.
* For post-amendment prospective enrollment, qualifying PSMA PET performed within 60 days before enrollment and index PDRT planned to begin within 60 days after the scan.
* Availability of the qualifying PET date, systemic-therapy dates, locked metastatic-lesion count, separate local-site count, lesion map, and eligibility decision. For retrospective inclusion, PDRT exposure and at least one outcome or censoring time must also be determinable.

Exclusion Criteria

* Limited progression defined only by conventional CT, MRI, or bone scintigraphy without a qualifying PSMA PET examination.
* More than five qualifying progressing metastatic lesions for retrospective or pre-amendment inclusion.
* More than 10 qualifying progressing metastatic lesions after amendment activation.
* Diffuse, non-enumerable, or rapidly progressive disease that is not considered suitable for comprehensive lesion-directed radiotherapy.
* Any known active metastatic or local progressing site that cannot be included in the comprehensive PDRT plan.
* Clinical deterioration or an urgent systemic-treatment indication that makes comprehensive PDRT inappropriate or unsafe.
* Radiotherapy delivered solely with palliative symptom-control intent rather than definitive progression-directed local-control intent.
* For prospective participation, inability to complete the approved consent process.
* For retrospective cases, missing baseline imaging or core dates such that metastatic burden, PDRT exposure, or at least one outcome or censoring time cannot be determined reliably.

Where it's running

• Affidea Nu-Med Cancer Diagnostics and Therapy Center
  Zamość, Lublin Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Mateusz Bilski, MD, PhD
• Email: mateusz.bilski@affidea.com
• Phone: 84 535 99 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.