Radiotherapy aimed at a few growing spots in metastatic prostate cancer
Follows adults with prostate cancer whose few spreading spots receive targeted radiotherapy.
Plain-language title generated from the registry record
Registry title: PSMA PET-Staged Comprehensive Progression-Directed Radiotherapy for Limited Progression in Prostate Cancer
Key facts
- Where
- Zamość, PolandSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and has started to grow in only a few places while on drug treatment. These places must be treatable with radiotherapy.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma that has spread (hormone-sensitive or castration-resistant) with limited progression: 1-5 growing spread lesions, or 1-10 for people enrolled after the protocol amendment. Growth in the prostate or prostate bed must also be treatable.
- Earlier treatment
- Must be on active systemic anticancer therapy when the limited progression is assessed.
- Biomarker or test result
- A qualifying PSMA PET/CT or PSMA PET/MRI scan is required. For enrolment after the amendment, the scan must be done within 60 days before enrolment.
Main reasons for not taking part
- Limited progression seen only on conventional CT, MRI or bone scan, without a PSMA PET scan
- More than 5 growing lesions (retrospective or before the amendment) or more than 10 (after it)
- Widespread, uncountable or fast-growing disease
- A growing site that cannot be included in the radiotherapy plan
- Radiotherapy given only to relieve symptoms
Read by machine on 13 November 2026.
Where in Poland
- Affidea Nu-Med Cancer Diagnostics and Therapy CenterZamość, PolandContact: Mateusz Bilski, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
- Trial code
- NCT07691697
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Exclusion: Radiotherapy delivered solely with palliative symptom-control intent rather than definitive progression-directed local-control intent; Diffuse, non-enumerable, or rapidly progressive disease that is not considered suitable for comprehensive lesion-directed radiotherapy; 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; 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; 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.
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.