Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

• Status: Not yet recruiting
• Trial end date: 2030-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on enzalutamide to standard of care radiation and hormone therapy improve quality of life.

Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1) or standard of care radiation and hormone (ADT) therapy plus oral enzalutamide for 8 months (Arm 2). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Astellas Pharma Inc

Criteria

Inclusion Criteria:

1. Age > 18 years

2. Able to provide informed consent

3. Histologic diagnosis of prostate adenocarcinoma

4. ECOG performance status 0-2

5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases

1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)

2. Additional metastases can be detectable by PSMA PET only

6. All sites of disease are amenable to and can be safely treated with radiotherapy

7. Patients decline continuous use of ADT

Exclusion Criteria:

1. Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT

2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively

3. Prior use of salvage systemic therapy

4. Evidence of spinal cord compression