Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

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.).

Participants in this group will receive standard of care radiation treatment and ADT, plus enzalutamide. 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 enzalutamide orally (by mouth) daily for 8 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.

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

Enzalutamide

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

Standard of Care SBRT and ADT

Andrew McPartlin, MD

This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on enzalutamide 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 enzalutamide for 8 months (Arm 2). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

Male participants only as this study is in metastatic prostate cancer.

Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate

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

Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (EPIC-26).

Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-P).

Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-Fatigue).

Determine if the addition of intermittent enzalutamide to standard of care treatment results in a physician-reported difference in acute and late toxicities compared to standard of care treatment alone assessed by CTCAE Toxicity 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)	NCT05404139	Metastatic Pros...	Enzalutamide Standard of Car...	18 Years - 100 Years	University Health Network, Toronto
Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)	NCT05404139	Metastatic Pros...	Enzalutamide Standard of Car...	18 Years - 100 Years	University Health Network, Toronto

Spots Global Cancer Trial Database for standard of care sbrt and adt