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

NCT05404139 | Recruiting Phase 2

• 1 other identifier: 22-5274
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Determine if progression free survival improves with the addition of short-term ARPI (abiraterone or abiraterone) with or without statin (atorvastatin) to standard of care treatment.

  5 years

Secondary Outcomes (6)

• Patient-reported quality of life

  5 years

• Patient-reported quality of life

  5 years

• Physician-reported toxicity

  5 years

• Time to Testosterone Recovery

  5 years

• Improvement in Metabolic Parameters

  5 years

Study Arms (3)

Arm 1 - Standard of Care

OTHER

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.).

Other: Standard of Care SBRT and ADT

Arm 3 - Study Treatment (Abiraterone)

EXPERIMENTAL

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.

Drug: Abiraterone; Other: Standard of Care SBRT and ADT

Arm 4: Study Treatment (Abiraterone + Atorvastatin)

EXPERIMENTAL

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.

Drug: Abiraterone; Other: Standard of Care SBRT and ADT; Drug: Atorvastatin

Interventions

Abiraterone DRUG

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

Arm 3 - Study Treatment (Abiraterone); Arm 4: Study Treatment (Abiraterone + Atorvastatin)

Standard of Care SBRT and ADT OTHER

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

Arm 1 - Standard of Care; Arm 3 - Study Treatment (Abiraterone); Arm 4: Study Treatment (Abiraterone + Atorvastatin)

Atorvastatin DRUG

Lipid metabolism regulator

Arm 4: Study Treatment (Abiraterone + Atorvastatin)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT
• History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
• Prior use of salvage systemic therapy
• Evidence of spinal cord compression
• ALT/AST \> 3 x ULN
• History of myasthenia gravis or active myasthenia gravis
• History of ocular myasthenia or active ocular myasthenia

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Astellas Pharma Inc: collaborator

Study Sites (2)

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Sunnybrook Research Institute

Toronto, Ontartio, M4N 3M5, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; Androgen Antagonists; Atorvastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Rachel Glicksman, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 3, 2022
• Study Start: May 24, 2023
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CA (2)