High dose Radiation therapy to eradicate early metastatic prostate cancer as an alternative to hormone or chemotherapy: a prospective phase II study

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12618000566235
• Lead Sponsor: Integrated Clinical Oncology Network Pty Ltd (ICON)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-13
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 208

Inclusion Criteria

Histologically confirmed diagnosis of prostate cancer.
- Biochemical relapses of prostate cancer following radical local treatment.
- Males aged 18 years to 80 years inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- N1 and M1 a/b disease on imaging, with a combined maximum of five synchronous lesions
- Exclusion of local relapse.
- Metastases suitable for ablative radiotherapy

Exclusion Criteria

- No prior palliative radiotherapy (definitive radiotherapy as part of initial management is allowed).
- Active local disease on clinical examination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients not requiring treatment escalation at 5 and 10 years. These data will be collected through scheduled patient assessments and medical records. [ 6 weeks post-radiotherapy, three monthly until two years post-radiotherapy, six monthly until five years and then annually up to 10 years post-radiotherapy. The primary outcome will be assessed as time to event over the give year period.]