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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Age \> 18 years

• Able to provide informed consent

• Histologic diagnosis of prostate adenocarcinoma

• ECOG performance status 0-2

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

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

⁃ Additional metastases can be detectable by PSMA PET only

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

• Patients decline continuous use of ADT

Locations
Other Locations
Canada
Princess Margaret Cancer Center
RECRUITING
Toronto
Sunnybrook Research Institute
ACTIVE_NOT_RECRUITING
Toronto
Contact Information
Primary
Rachel Glicksman, MD
rachel.glicksman@uhn.ca
416-946-4961
Time Frame
Start Date: 2023-05-24
Estimated Completion Date: 2026-03
Participants
Target number of participants: 132
Treatments
Other: 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.).
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Astellas Pharma Inc
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov

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