Clinical trial · Interventional
Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer
Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accruals
Summary
Brief summary (as posted)
Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Sensitive Oligometastatic Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR (19Gy) or SBRT (35-40Gy) | Radiation | — | UNRESOLVED |
| Radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Radical prostatectomy
- interventionNames
- Procedure: Radical prostatectomy
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Radiotherapy
- interventionNames
- Radiation: HDR (19Gy) or SBRT (35-40Gy)
Primary outcomes (1)
- measure
- Patients willing to accept their randomization
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent. * Histologic confirmation of prostate adenocarcinoma. * Stage IV disease with ≤ 5 metastases outside of the pelvis. * ≤ 3 metastases in any one organ system. * ECOG performance 0-1. * All metastatic tumours amenable to SBRT. * Patient eligible for either RP or RT to the prostate. Exclusion Criteria: * Castration resistant prostate cancer. * Previous RP or RT to prostate. * Inability to treat all metastases with SBRT. * Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.
References
Publications (0)
Data not yet available