Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

NCT ID: NCT05404139

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-24
• Study Completion Date: 2026-03-31

Brief Summary

This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor 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 abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 - Standard of Care

Participants in this group will receive standard of care radiation treatment and ADT. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 4 months as per standard of care (for 8 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.).

Group Type: OTHER

Standard of Care SBRT and ADT

Intervention Type: OTHER

Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)

Arm 3 - Study Treatment

Participants in this group will receive standard of care radiation treatment and ADT, plus abiraterone. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 4 months as per standard of care (for 8 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). In addition, participants will take abiraterone orally (by mouth) daily for 8-9 months. Participants will start the first pill within a month of enrollment. This pill can be taken around the same time of day with or without food.

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Second-generation androgen pathway inhibitor (ARAT), oral tablet

Standard of Care SBRT and ADT

Intervention Type: OTHER

Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)

Interventions

Enzalutamide

Second-generation androgen pathway inhibitor (ARAT), oral tablet

Intervention Type: DRUG

Standard of Care SBRT and ADT

Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status: RECRUITING

Sunnybrook Research Institute

Toronto, Ontartio, Canada

Site Status: ACTIVE_NOT_RECRUITING

Countries

Canada

Central Contacts

Rachel Glicksman, MD

Role: CONTACT

rachel.glicksman@uhn.ca

416-946-4961

Facility Contacts

Andrew McPartlin, MD

Role: primary

andrew.mcpartlin@rmp.uhn.ca

416-946-2132

Other Identifiers

22-5274

Identifier Type: -

Identifier Source: org_study_id