๐ฌIn plain words
What the trial is, and whether it could suit you
PSMA-OLIGO-PRO is a multicenter, ambispective, observational real-world evidence registry of adults with metastatic hormone-sensitive or metastatic castration-resistant prostate cancer who develop a limited number of progressing metastatic lesions during active systemic therapy and are considered for comprehensive progression-directed radiotherapy (PDRT) in routine clinical care. The registry includes retrospective cases treated before June 26, 2026, and prospective cases enrolled from June 26, 2026, onward. Before the site-specific protocol amendment takes effect, the metastatic-lesion ceiling is 1-5. After the amendment takes effect, prospective candidates with 1-10 qualifying progressing metastatic lesions on baseline PSMA PET/CT or PSMA PET/MRI may be included. Metastatic burden is prespecified as 1-5 lesions, representing classical oligoprogression, or 6-10 lesions, representing exp
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
* 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.
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What it tests
- Comprehensive Progression-Directed Radiotherapy
Affidea Nu-Med Cancer Diagnostics and Therapy Center
Zamoลฤ, Poland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.