Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer (CONSORT-PC)

University Health Network, Toronto

Status and phase: Enrolling; Phase 2

Conditions: Prostate Metastases

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05656794

22-5921

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm 1 - Investigational

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy

Arm 2 - Standard

Other group

Description:

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

Treatment:

Radiation: Radiotherapy