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Androgen Receptor Antagonist
Hormone Therapy + Radiation for Prostate Cancer
Phase 2
Recruiting
Led By Martin T. King, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 at the time of consent
Gleason 7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new hormone therapy given with radiation to treat intermediate risk prostate cancer. They want to see if it is as effective as the standard hormone therapy while also preserving erectile function.
Who is the study for?
Men over 18 with intermediate risk prostate cancer (T2b-T2c, Gleason 7, PSA 10-20 ng/mL) who have good erectile function and can swallow pills. They must not have had certain previous treatments for prostate cancer or other conditions that overlap with the trial's treatment areas. Participants need to agree to use contraception and should be able to undergo radiation therapy.Check my eligibility
What is being tested?
The study is testing a new hormonal therapy combined with radiation against standard hormone therapy in treating intermediate risk prostate cancer. The goal is to see if the new therapy works as well while better preserving erectile function.See study design
What are the potential side effects?
Possible side effects include those typical of hormone therapies such as hot flashes, fatigue, decreased libido, and gastrointestinal issues. Radiation may cause skin irritation at the site of treatment, tiredness, and mild digestive problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My prostate cancer has a Gleason score of 7.
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My cancer is classified as T2b or T2c.
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My prostate cancer has a Gleason score of 7 (4+3).
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My kidney function is good.
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I am fully active or can carry out light work.
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I am a candidate for radiation therapy aimed at curing my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of patients with a PSA nadir <= 0.5
Secondary outcome measures
Cardiovascular events
Cause specific survival
Global health impact as measured by Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Score
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Darolutamide+Radiation TherapyExperimental Treatment2 Interventions
Darolutamide is administered orally twice daily
Radiation therapy is administered starting 4-16 weeks after Darolutamide
Group II: Bicalutamide+GnRH Agonist+Radiation TherapyExperimental Treatment3 Interventions
Bicalutamide is administered orally on a daily basis
GnRH Agonist as prescribed
Radiation therapy is administered starting 4-16 weeks after ADT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Darolutamide
2018
Completed Phase 2
~100
Bicalutamide
2003
Completed Phase 3
~5330
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,761 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,885 Patients Enrolled for Prostate Cancer
Decipher BiosciencesUNKNOWN
1 Previous Clinical Trials
5,000 Total Patients Enrolled
1 Trials studying Prostate Cancer
5,000 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,557 Total Patients Enrolled
38 Trials studying Prostate Cancer
25,699 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is at an intermediate stage, with specific test results.I am 18 years old or older.My prostate cancer has a Gleason score of 7.I have been treated with specific prostate cancer drugs for more than 28 days.You can easily swallow pills.I have 2-3 risk factors for my condition.I can provide tissue for a Decipher test or already have a Decipher score.I have undergone orchiectomy or been on hormonal therapy for cancer.My cancer is classified as T2b or T2c.I have not taken finasteride or dutasteride in the last 28 days.I have been treated with hormone therapy for cancer.My prostate cancer has a Gleason score of 7 (4+3).I do not have any severe illnesses or social situations that would stop me from following the study's requirements.This criterion needs more specific details.I agree to use effective birth control methods during the study and for 3 months after.I have had radiation therapy in the same area where I would receive current treatment.My cancer has spread and this was confirmed by a CT scan or other imaging tests.My cancer is currently being treated.My blood pressure is high and not treated, but it was lower in a recent check.I have signed the consent form and agree to share my health information.I haven't had severe heart issues, blood clots, serious liver problems, or HIV in the last 6 months.You are able to have strong and satisfying erections during sexual activities.I have had surgery or specific treatments for prostate cancer.My oncologist thinks my cancer might come back within 5 years.I have Gilbert's syndrome but my direct bilirubin levels are within the acceptable range.I can follow the study's procedures for its duration.You have had allergic reactions in the past to drugs that are similar to the ones used in this study.My kidney function is good.My blood, kidney, and liver functions are all within normal ranges.My kidney function is within normal ranges.My lymph nodes are enlarged but tested negative for cancer.I stopped using estrogen and testosterone treatments as required before testing.My hormone levels are relevant to my condition.My prostate cancer was confirmed by a biopsy within the last year.My prostate is smaller than 90 cc as measured by imaging.I am fully active or can carry out light work.I use erectile aids that are not oral PDE-5 inhibitors.I have not had another type of cancer.I have received chemotherapy for prostate cancer.I am a candidate for radiation therapy aimed at curing my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Darolutamide+Radiation Therapy
- Group 2: Bicalutamide+GnRH Agonist+Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this research?
"The clinicaltrials.gov page establishes that this trial is actively recruiting participants, having been posted on June 1st 2020 and revised as recently as May 12th 2022."
Answered by AI
How many participants have been approved for this research project?
"This study necessitates 220 participants that fulfill the required inclusion criteria. The pharmaceutical giant Bayer will be managing this trial at NYU Winthrop in Garden City, New york and Stamford Hospital in Connecticut respectively."
Answered by AI
Could you confirm how many different North American locations are hosting this clinical experiment?
"NYU Winthrop in Garden City, New york; Stamford Hospital in Stamford, Connecticut; and Beth Israel Deaconness Medical Center in Boston, Massachusetts are the primary sites for this investigation. Additionally there are 5 additional locations that contribute to its efforts."
Answered by AI
Is this medical experiment the first of its kind?
"AstraZeneca first conducted trials for Darolutamide in 2000, involving 600 participants. This resulted in the drug's Phase 3 approval and today there are 96 active studies spanning 1183 cities and 50 nations."
Answered by AI
What is the status of Darolutamide's authorization with the FDA?
"As this is a Phase 2 clinical trial, there is partial evidence of Darolutamide's safety, earning it an estimated score of two."
Answered by AI
Has Darolutamide been experimented with in the past?
"Currently, there are 96 clinical investigations being conducted in regard to Darolutamide, with 31 of them already at Phase 3. Most studies associated with this treatment are based out of Barcelona, Catalunya; however, 5,803 locations globally have been recruited for the purpose of these experiments."
Answered by AI
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