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

Condition(s) studied

Investigational drug(s) / intervention(s)

Comprehensive Progression-Directed Radiotherapy: Observed routine-care exposure includes definitive-intent radiotherapy planned for every qualifying metastatic site and for local or prostate-bed progressing sites identified in the index episode. Treatment may include stereotactic body radiotherapy, moderately hypofractionated external-beam radiotherapy, high-dose-rate or low-dose-rate brachytherapy, combined external-beam and brachytherapy, or mixed-modality radiotherapy. The registry does not assign treatment. Treatment modality, dose, fractionation, timing, site-level completion, and reasons for non-start or incomplete treatment are recorded.

Study summary

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 exploratory, PSMA PET-defined, limited progression. Intraprostatic and prostate-bed progressing foci are recorded separately from the metastatic count and must also be included in the comprehensive PDRT plan. Otherwise eligible local-only episodes form a separate descriptive stratum. All qualifying metastatic and locally progressing sites must be deemed technically amenable to definitive-intent PDRT before prospective analytic-cohort enrollment. The registry does not assign imaging, systemic therapy, or radiotherapy; these clinical decisions are made independently by the treating team in routine care. A qualifying baseline PSMA PET and documentation of comprehensive treatability are required for inclusion.

The primary endpoint is time to next systemic therapy in the continuation-plan treatment-start set. Key secondary outcomes include PDRT initiation and comprehensive implementation, time to widespread or non-PDRT-amenable progression, classical time to polymetastatic progression in the baseline 1-5 cohort, radiographic progression-free survival, lesion-level local control, overall survival, and treatment-related toxicity. The prespecified 1-5 versus 6-10 comparison is restricted to concurrent post-amendment prospective participants and is exploratory.

Eligibility

Primary outcome measure(s)

• Time to Next Systemic Therapy in the Continuation-Plan Treatment-Start Set — From first index PDRT fraction to a new systemic therapy line, death, last adequate assessment, or study data cutoff, up to 5 years
  Time from the first PDRT fraction to initiation of the first new systemic anticancer therapy line among participants who receive at least one PDRT fraction, whose management plan documented before PDRT was continuation of the same systemic regimen, and who had not initiated a new systemic line before the first PDRT fraction. Death before initiation of a new line is treated as a competing event; otherwise, participants are censored at the last adequate assessment.

Trial sites (1)

More Affidea Nu-med Center of Oncological DIagnostics and Therapy trials in Poland

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