Clinical trial · Interventional
Stereotactic Radiotherapy for Oligometastatic Prostate Cancer
Comprehensive Stereotactic Radiotherapy for Oligometastatic Prostate Cancer: A Phase I/II Study
NCT02563691CI-TRIAL-00056968CROPunknownPhase 1 / Phase 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 study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic radiotherapy
- description
- Stereotactic radiotherapy will be delivered to the prostate (if not previously treated) and to all metastatic tumours.
- interventionNames
- Radiation: stereotactic radiotherapy
Primary outcomes (1)
- measure
- Incidence of late radiotherapy toxicities after stereotactic radiotherapy to all sites of disease
- timeFrame
- cumulative incidence at 2 years
- description
- common terminology criteria for adverse events (CTCAE) version 4.0
Secondary outcomes (5)
- measure
- Quality of Life (EORTC QLQ-C30)
- timeFrame
- proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent. * ECOG performance status 0-1. * Histologic confirmation of prostate adenocarcinoma. * Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes. * ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases). * All sites of disease are amenable to stereotactic radiotherapy. Exclusion Criteria: * Castrate resistant prostate cancer. * Evidence of spinal cord compression. * Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy). * Inability to safely treat all sites of visible disease. * Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.