PSMA PET-Guided Progression-Directed Radiotherapy for Oligoprogressive Prostate Cancer (PSMA-OLIGO-PRO)

July 2, 2026 updated by: Mateusz Bilski, Affidea Nu-med Center of Oncological DIagnostics and Therapy

Outcomes After PSMA PET-Guided Progression-Directed Radiotherapy, Including SBRT and Brachytherapy, for Oligoprogressive Prostate Cancer: An Ambispective Multicenter Real-World Evidence Cohort Study

PSMA-OLIGO-PRO is a multicenter ambispective observational real-world registry evaluating outcomes after PSMA PET-guided progression-directed radiotherapy for oligoprogressive prostate cancer. The registry includes retrospectively identified patients treated before June 26, 2026 and prospectively enrolled patients from June 26, 2026 onward.

Eligible patients have metastatic hormone-sensitive or castration-resistant prostate cancer, are receiving active systemic therapy, and develop a limited number of new or regrowing lesions while the remaining disease sites are controlled. Oligoprogression is primarily defined by PSMA PET/CT or PSMA PET/MR, with MRI used when clinically appropriate, particularly for intraprostatic, local, or prostate-bed progression.

Participants are not assigned to treatment by the registry protocol. All imaging, systemic therapy, radiotherapy modality, dose, fractionation, and follow-up decisions are made by treating physicians as part of routine clinical care. Progression-directed radiotherapy may include stereotactic body radiotherapy for nodal, bone, visceral, or local lesions, moderately hypofractionated external beam radiotherapy when clinically selected, and brachytherapy when appropriate for intraprostatic, prostate-bed, or selected metastatic oligoprogressive lesions.

The registry evaluates whether treating all identifiable oligoprogressive lesions can delay escalation to a new systemic therapy line, preserve the oligometastatic state, maintain local control, and provide acceptable safety in contemporary PSMA PET-guided practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PSMA-OLIGO-PRO is a multicenter ambispective observational real-world evidence registry of patients with prostate cancer who develop limited oligoprogression during otherwise active systemic therapy and undergo lesion-directed radiotherapy in routine clinical practice. The study includes retrospective data from patients treated before June 26, 2026 and prospective data from patients enrolled from June 26, 2026 onward.

Oligoprogression is defined as the occurrence of up to five new and/or regrowing lesions detected on PSMA PET/CT or PSMA PET/MR while other known disease sites remain controlled under ongoing systemic therapy. MRI may be used as a complementary imaging modality when clinically appropriate, especially for intraprostatic recurrence, local recurrence, or prostate-bed progression. Oligoprogression will be categorized according to the ESTRO/EORTC oligometastatic disease framework, including metachronous oligoprogression, repeat oligoprogression, and induced oligoprogression.

Participants are not assigned to any intervention by the registry protocol. The registry does not mandate imaging, systemic therapy, radiotherapy, dose, fractionation, target definition, treatment planning, or follow-up schedules. All clinical decisions are made by treating physicians according to institutional standards, multidisciplinary assessment, available imaging, patient condition, previous treatment history, and local practice.

The exposure of interest is PSMA PET-guided progression-directed radiotherapy delivered with ablative or definitive local intent to all identifiable oligoprogressive lesions. Radiotherapy may include stereotactic body radiotherapy for nodal, bone, visceral, or selected local lesions; moderately hypofractionated external beam radiotherapy when clinically selected; and high-dose-rate or other brachytherapy approaches when appropriate. Brachytherapy may be considered for intraprostatic or prostate-bed oligoprogressive recurrence and, in selected cases, for technically suitable metastatic lesions such as liver metastases, according to institutional expertise and clinical judgment.

The study population includes patients with metastatic hormone-sensitive prostate cancer or metastatic castration-resistant prostate cancer who are receiving active systemic therapy at the time of oligoprogression. Systemic therapy may be continued, modified, or escalated according to routine clinical decision-making. The registry is designed to evaluate whether local treatment of all oligoprogressive lesions can prolong benefit from the current systemic therapy line, delay the need for systemic treatment escalation, and preserve the oligometastatic state.

The primary endpoint is time to next systemic therapy escalation, defined as the time from the start of the index progression-directed radiotherapy course to initiation of a new systemic therapy line. Key secondary endpoints include time to polymetastatic progression, radiographic progression-free survival, overall survival, local control of treated lesions, repeat oligoprogression, use of subsequent lesion-directed therapy, patterns of disease progression, and treatment-related adverse events.

Safety will be assessed using adverse events recorded in routine clinical care and graded according to CTCAE version 5.0 when sufficient information is available. Acute and late adverse events will be described separately. Exploratory analyses will evaluate clinical, imaging, disease-related, and treatment-related factors associated with delayed systemic therapy escalation, durable local control, and preservation of an oligometastatic disease state.

Because this is an observational registry, the study aims to describe real-world outcomes after contemporary PSMA PET-guided progression-directed radiotherapy rather than test a protocol-assigned treatment strategy. The results are intended to support patient selection, multidisciplinary decision-making, and future prospective studies of oligoprogressive prostate cancer.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Lublin Voivodeship
      • Zamość, Lublin Voivodeship, Poland, 22-400
        • Recruiting
        • Affidea Nu-Med Cancer Diagnostics and Therapy Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mateusz Bilski, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults with metastatic prostate cancer who develop PSMA PET-defined oligoprogression during otherwise active systemic therapy and undergo progression-directed radiotherapy in routine clinical practice. The registry includes patients with metastatic hormone-sensitive and metastatic castration-resistant prostate cancer treated with SBRT, moderately hypofractionated external beam radiotherapy, brachytherapy, combined approaches, or mixed-modality radiotherapy when clinically appropriate.

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of prostate cancer.
  • Metastatic hormone-sensitive prostate cancer or metastatic castration-resistant prostate cancer.
  • Receiving active systemic therapy at the time of oligoprogression.
  • Oligoprogression defined as up to five new and/or regrowing lesions detected on PSMA PET/CT or PSMA PET/MR, with other known disease sites remaining controlled.
  • Planned or completed PSMA PET-guided progression-directed radiotherapy to all clinically relevant oligoprogressive lesions as part of routine clinical care.
  • Radiotherapy may include stereotactic body radiotherapy, moderately hypofractionated external beam radiotherapy, brachytherapy, combined external beam radiotherapy and brachytherapy, or mixed-modality radiotherapy, when clinically appropriate.
  • Availability of baseline clinical, imaging, treatment, and follow-up data sufficient for registry endpoints.

Exclusion Criteria:

  • Polymetastatic progression not consistent with an oligoprogressive state at the time of index radiotherapy.
  • More than five new or regrowing lesions at the index oligoprogression episode.
  • Radiotherapy delivered with purely palliative symptom-control intent rather than progression-directed local control intent.
  • Lack of sufficient clinical, imaging, treatment, or follow-up information for endpoint assessment.
  • Any condition that, in the opinion of the treating physician or investigator, makes registry inclusion inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PSMA PET-Guided PDRT Registry Cohort
Single observational cohort of patients with metastatic hormone-sensitive or castration-resistant prostate cancer who develop PSMA PET-defined oligoprogression during active systemic therapy and undergo progression-directed radiotherapy in routine clinical practice. Patients may contribute retrospective data, retrospective data with prospective follow-up updates, or fully prospective data, depending on treatment and enrollment timing.
Radiation: Progression-Directed Radiotherapy
Progression-directed radiotherapy delivered with ablative or definitive local intent to all identifiable PSMA PET-defined oligoprogressive lesions as part of routine clinical care. Treatment may include stereotactic body radiotherapy, moderately hypofractionated external beam radiotherapy, brachytherapy for intraprostatic or prostate-bed recurrence, or brachytherapy for selected metastatic lesions when clinically appropriate.
Other Names:
  • SBRT
  • Stereotactic Body Radiotherapy
  • Brachytherapy
  • MDT
  • PDRT
  • Metastasis-Directed Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Next Systemic Therapy Escalation
Time Frame: From start of index progression-directed radiotherapy to initiation of a new systemic therapy line, assessed up to 5 years
Time from the start date of index progression-directed radiotherapy for the oligoprogression episode to initiation of a new systemic therapy line. Participants without systemic therapy escalation will be censored at last available follow-up.
From start of index progression-directed radiotherapy to initiation of a new systemic therapy line, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Polymetastatic Progression
Time Frame: From start of index progression-directed radiotherapy to polymetastatic progression, assessed up to 5 years
Time from the start date of index progression-directed radiotherapy to first documentation of progression beyond the oligoprogressive state and no longer considered amenable to lesion-directed radiotherapy alone.
From start of index progression-directed radiotherapy to polymetastatic progression, assessed up to 5 years
Radiographic Progression-Free Survival
Time Frame: From start of index progression-directed radiotherapy to radiographic progression or death, assessed up to 5 years
Time from the start of index progression-directed radiotherapy to radiographic disease progression or death from any cause, whichever occurs first.
From start of index progression-directed radiotherapy to radiographic progression or death, assessed up to 5 years
Overall Survival
Time Frame: From start of index progression-directed radiotherapy to death from any cause, assessed up to 5 years
Time from the start of index progression-directed radiotherapy to death from any cause.
From start of index progression-directed radiotherapy to death from any cause, assessed up to 5 years
Local Control of Treated Lesions
Time Frame: From completion of index progression-directed radiotherapy to local progression of treated lesions, assessed up to 5 years
Proportion of treated lesions without in-field local progression during follow-up, assessed according to routine imaging and clinical documentation.
From completion of index progression-directed radiotherapy to local progression of treated lesions, assessed up to 5 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Time Frame: From start of index progression-directed radiotherapy through follow-up, assessed up to 5 years.
Number of participants with acute or late treatment-related adverse events recorded during routine clinical care and graded according to CTCAE version 5.0 when sufficient information is available.
From start of index progression-directed radiotherapy through follow-up, assessed up to 5 years.
Repeat Oligoprogression
Time Frame: From start of index progression-directed radiotherapy to repeat oligoprogression, assessed up to 5 years
Occurrence of a subsequent limited oligoprogressive episode after index progression-directed radiotherapy that remains potentially amenable to further lesion-directed radiotherapy.
From start of index progression-directed radiotherapy to repeat oligoprogression, assessed up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants by First Documented Disease Progression Pattern
Time Frame: From start of index progression-directed radiotherapy to first documented progression, assessed up to 5 years.
Number of participants classified according to the first documented progression pattern after index progression-directed radiotherapy. Progression pattern will be assigned as one prespecified category based on investigator assessment of routine imaging and clinical documentation.
From start of index progression-directed radiotherapy to first documented progression, assessed up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affidea Nu-med Center of Oncological DIagnostics and Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2026

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2031

Study Registration Dates

First Submitted

June 28, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSMA-OLIGO-PRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in future publications may be shared upon reasonable request. Shared data may include baseline clinical and disease characteristics, PSMA PET-defined oligoprogression characteristics, radiotherapy modality, dose and fractionation, systemic therapy information, follow-up, progression, survival, and toxicity outcomes. Data will be shared only after approval by the study steering group and, where required, relevant ethics or data-protection bodies.

IPD Sharing Time Frame

Beginning 12 months after publication of the main study results and available for 5 years.

IPD Sharing Access Criteria

Access may be granted to qualified researchers submitting a methodologically sound proposal, subject to approval by the study steering group, compliance with applicable data-protection regulations, and completion of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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