Clinical trial · Interventional
Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer
Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
NCT05656794CI-TRIAL-00106258CONSORT-PCrecruitingPhase 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 prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
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 |
|---|---|---|---|
| Prostate Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 - Investigational
- description
- Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).
- interventionNames
- Radiation: Radiotherapy
- type
- OTHER
- label
- Arm 2 - Standard
- description
- Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Rates of acute toxicity
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven prostate cancer * Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.) * Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.) * Planned for EBRT * ECOG 0 or 1 * Age 18 years or older Exclusion Criteria: * Prior radiotherapy to pelvis * Active ulcerative colitis or Crohn's Disease, at discretion of treating physician * Any condition where radiotherapy is contraindicated
References
Publications (0)
Data not yet available
No reference posted for this study.