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RECRUITING

NCT07691697

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

Sponsor: Affidea Nu-med Center of Oncological DIagnostics and Therapy

View on ClinicalTrials.gov

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.

Official title: Outcomes After PSMA PET-Staged Comprehensive Progression-Directed Radiotherapy for Limited Progression in Prostate Cancer: An Ambispective Multicenter Registry With a Prospective 1-10-Metastasis Cohort

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-06-26

Completion Date

2031-12-30

Last Updated

2026-09-17

Healthy Volunteers

Conditions

Oligoprogressive Prostate Cancer Metastatic Prostate Cancer

Interventions

RADIATION

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.

* 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.

Locations (1)

Affidea Nu-Med Cancer Diagnostics and Therapy Center

Zamość, Lublin Voivodeship, Poland