Recruiting
Phase 2

Androgen Receptor Pathway Inhibitor

Sponsor:

University Health Network, Toronto

Code:

NCT05404139

Conditions

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Abiraterone

Standard of Care SBRT and ADT

Atorvastatin

Study Details

Brief summary:

This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin 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), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

Conditions

Metastatic Prostate Cancer

Study ID

NCT05404139

Start date

May 24, 2023

Status verified date

Jul, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 (for all patients):

1. Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT

a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and 3.
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

Exclusion Criteria (for Arm 4 only, after randomization)

1. ALT/AST > 3 x ULN
2. History of myasthenia gravis or active myasthenia gravis
3. History of ocular myasthenia or active ocular myasthenia

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 3-4 months as per standard of care (for 8-9 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 (Abiraterone)

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 3-4 months as per standard of care (for 8-9 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.

experimental: Arm 4: Study Treatment (Abiraterone + Atorvastatin)

Participants in this group will receive standard of care radiation treatment and ADT, plus abiraterone and atorvastatin. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3 or 4 months as per standard of care (for 8-9 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. Participants will also take atorvastatin once daily by mouth for 2 years. This may also be taken with or without food.

Interventions

Abiraterone

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

Standard of Care SBRT and ADT

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

Atorvastatin

Lipid metabolism regulator

Primary outcome measure

  • Progression free survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Rachel Glicksman, MD

416-946-4961rachel.glicksman@uhn.ca

Locations

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Rachel Glicksman, MD

416-946-4501rachel.glicksman@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-07-27.