Clinical trial · Interventional
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
NCT06927635CI-TRIAL-00117006SECURErecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castrate Resistance Prostate Cancer | — | UNRESOLVED | — |
| OligoProgressive Metastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
| Systemic therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 - Standard of Care
- description
- Participants on Arm 1 - SOC will be treated as per standard of care by their treating Oncologist. In most instances, it is anticipated participants will undergo a change in Systemic Therapy (ST) (including best supportive care). The ST will be at the discretion of the Oncologist and patient, according to best practices for the patient's diagnosis and clinical scenario. Patients can receive palliative radiotherapy for standard indications at any time.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
- Other: Systemic therapy
- type
- EXPERIMENTAL
- label
- Arm 2 - Experimental
- description
- Participants on Arm 2 - Experimental will receive standard of care SBRT to oligoprogressive sites according to institutional standards while remaining on the systemic treatment prescribed by the treating oncologist.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
- Other: Systemic therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Able to provide informed consent * Histologic diagnosis of prostate adenocarcinoma * Castrate Resistance Prostate Cancer * Radiographic evidence of \<10 sites of extra-cranial OP metastatic lesions * Receiving any line of ST for \>3 months * All sites of OP disease are amenable to and can be safely treated with SBRT * ECOG performance status 0-3 Exclusion Criteria: * Evidence of spinal cord compression * Contraindication to radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.