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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05404139

Collaborator

Astellas Pharma Inc (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Cancer	Drug: Enzalutamide Other: Standard of Care SBRT and ADT	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2030

Anticipated Study Completion Date :

Jul 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
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.).	Other: Standard of Care SBRT and ADT Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)
Experimental: Arm 2 - Study Treatment 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.	Drug: Enzalutamide Second-generation androgen pathway inhibitor (ARAT), oral tablet Other: Standard of Care SBRT and ADT Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)

Arm

Intervention/Treatment

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.).

Other: Standard of Care SBRT and ADT

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

Experimental: Arm 2 - Study Treatment

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.

Drug: Enzalutamide

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

Other: Standard of Care SBRT and ADT

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

Outcome Measures

Primary Outcome Measures

Progression free survival [5 years]
Determine if progression free survival improves with the addition of intermittent enzalutamide to standard of care treatment.

Secondary Outcome Measures

Patient-reported quality of life [5 years]
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).
Patient-reported quality of life [5 years]
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).
Patient-reported quality of life [5 years]
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).
Physician-reported toxicity [5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Center	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto
Astellas Pharma Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT05404139

Other Study ID Numbers:

22-5274

First Posted:

Jun 3, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jun 3, 2022