Standard of Care SBRT and ADT for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Princess Margaret Cancer Center, Toronto, Canada
Prostate Cancer+1 More
Standard of Care SBRT and ADT - Other
Eligibility
18+
Male
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Prostate Cancer
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 5 years

5 years
Patient-reported quality of life
Physician-reported toxicity
Progression free survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Arm 2 - Study Treatment
1 of 1
Experimental Treatment

66 Total Participants · 1 Treatment Group

Primary Treatment: Standard of Care SBRT and ADT · No Placebo Group · Phase 2

Arm 2 - Study TreatmentExperimental Group · 2 Interventions: Standard of Care SBRT and ADT, Enzalutamide · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2060

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Closest Location: Princess Margaret Cancer Center · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2015First Recorded Clinical Trial
3 TrialsResearching Prostate Cancer
25 CompletedClinical Trials

Who is running the clinical trial?

Astellas Pharma IncIndustry Sponsor
678 Previous Clinical Trials
212,870 Total Patients Enrolled
35 Trials studying Prostate Cancer
8,635 Patients Enrolled for Prostate Cancer
University Health Network, TorontoLead Sponsor
1,351 Previous Clinical Trials
471,567 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,372 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a histologic diagnosis of prostate adenocarcinoma.
You have Stage IV castrate sensitive metastatic prostate cancer.
You have one or more metastatic deposits on conventional imaging.
Additional metastases can be detectable by PSMA PET only.
All sites of disease are amenable to and can be safely treated with radiotherapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.