Back to resultsDuration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Primary Purpose
Metastatic Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Enzalutamide
Standard of Care SBRT and ADT
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Princess Margaret Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Arm 1 - Standard of Care
Arm 2 - Study Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression free survival
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
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
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
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
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.
Full Information
NCT ID
NCT05404139
First Posted
May 19, 2022
Last Updated
June 2, 2023
Sponsor
University Health Network, Toronto
Collaborators
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT05404139
Brief Title
Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Official Title
Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Astellas Pharma Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Standard of Care
Arm Type
Other
Arm Description
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.).
Arm Title
Arm 2 - Study Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Intervention Description
Second-generation androgen pathway inhibitor (ARAT), oral tablet
Intervention Type
Other
Intervention Name(s)
Standard of Care SBRT and ADT
Intervention Description
Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)
Primary Outcome Measure Information:
Title
Progression free survival
Description
Determine if progression free survival improves with the addition of intermittent enzalutamide to standard of care treatment.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Patient-reported quality of life
Description
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).
Time Frame
5 years
Title
Patient-reported quality of life
Description
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).
Time Frame
5 years
Title
Patient-reported quality of life
Description
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).
Time Frame
5 years
Title
Physician-reported toxicity
Description
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.
Time Frame
5 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male participants only as this study is in metastatic prostate cancer.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew McPartlin, MD
Phone
416-946-2132
Email
andrew.mcpartlin@rmp.uhn.ca
Facility Information:
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew McPartlin, MD
Phone
416-946-2132
Email
andrew.mcpartlin@rmp.uhn.ca
12. IPD Sharing Statement
Learn more about this trial
Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
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