Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

NCT ID: NCT05656794

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2031-08-31

Brief Summary

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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

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Conditions

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Prostate Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 - Investigational

Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Arm 2 - Standard

Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.

Group Type OTHER

Radiotherapy

Intervention Type RADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Interventions

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Radiotherapy

Standard of care radiotherapy administered as per institutional guidelines.

Intervention Type RADIATION

Eligibility Criteria

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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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Peter Chung, MD

Role: CONTACT

416-946-4501 ext. 2126

Facility Contacts

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Peter Chung, MD

Role: primary

416-946-4501 ext. 2126

Other Identifiers

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22-5921

Identifier Type: -

Identifier Source: org_study_id

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