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: 132
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Determine if progression free survival improves with the addition of intermittent enzalutamide to standard of care treatment.

  5 years

Secondary Outcomes (4)

• Patient-reported quality of life

  5 years

• Patient-reported quality of life

  5 years

• Patient-reported quality of life

  5 years

• Physician-reported toxicity

  5 years

Study Arms (2)

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 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.).

Other: Standard of Care SBRT and ADT

Arm 3 - Study Treatment

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 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.

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

Interventions

Enzalutamide DRUG

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

Arm 3 - Study Treatment

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male participants only as this study is in metastatic prostate cancer.
• 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, enzalutamide 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

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

enzalutamide; Androgen Antagonists

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

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: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CA (2)