Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

Phase 2

Recruiting

• Conditions: Prostate Metastases
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT05656794
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Study First Posted: 2022-12-19
• Study Start: 2023-07-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Primary Completion: 2031-08
• Study Completion: 2031-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Histologically-proven metastatic 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

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Exclusion Criteria

• Prior radiotherapy to pelvis
• Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
• Any condition where radiotherapy is contraindicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Standard	Radiotherapy	Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
Arm 1 - Investigational	Radiotherapy	Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).

Primary Outcome Measures

Name	Time	Method
Rates of acute toxicity	5 years	Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
Rates of late toxicity.	5 years	Compare rates of late toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0
Measure failure-free survival	5 years	Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada