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Hormone Therapy

Enzalutamide + Standard Therapy for Prostate Cancer

Phase 2
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic diagnosis of prostate adenocarcinoma
Patients decline continuous use of ADT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is investigating whether adding the drug enzalutamide to standard radiation and hormone therapy can improve quality of life for men with prostate cancer. There are two groups of participants, one that will receive the standard therapy and one that will receive the standard therapy plus enzalutamide. Participants will be followed for up to 5 years.

Who is the study for?
Men over 18 with a specific type of prostate cancer that has spread only slightly (oligometastatic) and who haven't had certain other cancers or treatments in the last 5 years. They should be relatively healthy, able to consent, and not on continuous hormone therapy for their cancer.Check my eligibility
What is being tested?
The trial is testing if adding a drug called Enzalutamide to standard radiation and hormone therapy improves life quality for men with limited-spread prostate cancer. Participants are randomly chosen to receive either just the standard treatment or the standard plus Enzalutamide for eight months.See study design
What are the potential side effects?
Enzalutamide can cause fatigue, back pain, joint discomfort, hot flushes, diarrhea, and high blood pressure. Radiation may lead to skin irritation at the treated site and fatigue. Hormone therapy might result in hot flashes, sexual dysfunction, and bone thinning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate cancer.
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I choose not to use hormone therapy continuously.
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I have advanced prostate cancer with 1-10 metastases, diagnosed within the last 6 months.
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I am older than 18 years.
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All my cancer sites can be safely treated with radiation.
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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival
Secondary outcome measures
Patient-reported quality of life
Physician-reported toxicity

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 - Study TreatmentExperimental Treatment2 Interventions
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.
Group II: Arm 1 - Standard of CareExperimental Treatment1 Intervention
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.).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,114 Total Patients Enrolled
64 Trials studying Prostate Cancer
15,400 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,149 Total Patients Enrolled
36 Trials studying Prostate Cancer
8,643 Patients Enrolled for Prostate Cancer

Media Library

ADT (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05404139 — Phase 2
Prostate Cancer Research Study Groups: Arm 1 - Standard of Care, Arm 2 - Study Treatment
Prostate Cancer Clinical Trial 2023: ADT Highlights & Side Effects. Trial Name: NCT05404139 — Phase 2
ADT (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05404139 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would this clinical trial be most appropriate for?

"Prostate cancer patients that meet the age criteria of 18 to 100 years old may be accepted into this study, in which case they would become 1 of the 66 planned participants."

Answered by AI

What are the FDA-sanctioned treatments for SBRT and ADT?

"Standard of Care SBRT and ADT's safety is supported by some data, but not enough to give it a 3."

Answered by AI

Does this study have any room for new participants?

"The clinical trial documented on clinicaltrials.gov is not looking for new patients at this time. This may change in the future, as the study was last updated on October 6th, 2022. There are 1298 other trials that are presently recruiting patients."

Answered by AI

Are people over the age of 40 eligible to participate in this trial?

"The age requirement to participate in this study is between 18-100 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
2023. "Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05404139.
~44 spots leftby Mar 2026
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