Phase
Condition
Prostate Cancer, Early, Recurrent
Urologic Cancer
Prostate Cancer
Treatment
Bicalutamide
Darolutamide
Radiation Therapy
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed prostate adenocarcinoma by biopsy within 1 year (365 days)from registration. The most recent biopsy will determine eligibility
National Cancer Center Network (NCCN) intermediate risk prostate cancer, defined asclinical T2b-T2c, Gleason 7, or PSA 10-20 ng/mL. Patients who only have radiographicevidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasionradiographically) will not be excluded.
Able to characterize the number of unfavorable intermediate risk factors below:
2-3 intermediate risk factors
T2b-T2c
Gleason 7
PSA 10-20 ng/mL
Gleason 4+3 disease
Percent positive cores ≥ 50%
Tissue available for submission for Decipher genomic score from archived tissue.Patients who had tissue sent to Decipher but did not have sufficient tissue forprocessing will not be excluded. Patients who already have a Decipher score mustpresent official report documentation.
Able to undergo radiation therapy with curative intent
Age ≥ 18 at the time of consent.
Demonstrate adequate organ function (hematologic, renal, hepatic) within 3 months ofregistration
System Laboratory Value
Hematological:
Platelet count (plt) ≥ 100,000/ µL
Hemoglobin (Hgb) ≥ 9 g/dL
Absolute neutrophil count (ANC) ≥ 1000 cells/µL
Renal:
Glomerular filtration rate (GFR) ≥ 45 mL/min
CKD-EPI equation will be used to calculate GFR
Hepatic and Other:
Bilirubin ≤ 1.5 × upper limit of normal (ULN)
In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN,measure direct and indirect bilirubin; if direct bilirubin is ≤1.5 × ULN,subject may be eligible
Aspartate aminotransferase (AST) ≤ 2.5 × ULN
Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Serum Albumin > 3.0 g/dL
Serum potassium ≥ 3.5 mmol/L
Endocrine:
Testosterone ≥ 150 ng/dL
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Good erectile function, as assessed by 'firm enough for masturbation or foreplay' or 'firm enough for intercourse' response to the question "How would you describe theusual quality of your erections during the past 4 weeks" on the EPIC-26questionnaire
Agrees to use a condom and another effective method of birth control if he is havingsex with a woman of childbearing potential (defined as a premenopausal femalecapable of becoming pregnant) OR agrees to use a condom if he is having sex with awoman who is pregnant while on study drug and for 3 months following the last doseof study drug. It is recommended that men who have had a vasectomy more than a yearprior to trial registration use a condom. Must also agree not to donate sperm.
Ability to understand and comply with study procedures for the entire length of thestudy as determined by the site investigator or protocol designee
Written informed consent and HIPAA authorization for release of personal healthinformation prior to registration. Note: HIPAA authorization may be included in theinformed consent or obtained separately. Subject must have the ability to understandand willingness to sign the written informed consent document.
Ability to swallow pills.
For patients in whom SBRT/combination RT stratification is pre-specified, prostatevolume as determined by MRI, CT, or ultrasound to be less than 90 cc.
Exclusion
Exclusion Criteria:
Prior surgical, cryotherapy, or high-intensity focused ultrasound for prostatecancer
Prior orchiectomy or hormonal therapy (gonadotropin releasing hormone (GnRH)agonists, non-steroidal anti-androgens)
Prior treatment with a first generation AR inhibitor (e.g. bicalutamide, flutamide,nilutamide, cyproterone acetate) or second generation AR inhibitor (e.g.Enzalutamide, Apalutamide, or Darolutamide)
Prior treatment with other investigational AR inhibitors, CYP17 enzyme inhibitorsuch as abiraterone acetate, TAK-700, or oral ketoconazole longer than 28 days
Prior use of estrogens; patients who have used testosterone injections must haveceased utilization within 90 days prior to screening testosterone. Patients who haveused any other type of testosterone supplementation (e.g. patches) must have ceasedutilization within 45 days prior to screening testosterone.
Use of 5-α reductase inhibitors (finasteride, dutasteride) within 28 days ofrandomization.
Prior radiation therapy that would result in overlap of current radiation therapyfields
Prior chemotherapy for prostate cancer
Clinically positive lymph nodes by imaging, sampling, or dissection. Patients withlymph nodes greater than 1.5 cm on short axis will require a negative biopsy foreligibility.
Metastatic disease, as assessed by abdominal or pelvic computed tomography (CT) orother imaging modality. Patients with 3 intermediate risk factors will require a CTabdomen/pelvis and a bone scan or PET imaging (PSMA PET/CT, fluciclovine PET/CT,etc.).
Erectile aids other than oral phosphodiesterase (PDE)-5 inhibitors
History of any of the following: Severe or unstable angina, myocardial infarction,symptomatic congestive heart failure New York Heart Association (NYHA) class III orIV, arterial or venous thromboembolic events (e.g., pulmonary embolism,cerebrovascular accident including transient ischemic attacks), clinicallysignificant ventricular arrhythmias, moderate or severe hepatic impairment (ChildPugh Class B or C), viral hepatitis, or human immunodeficiency virus within 6 monthsprior to randomization.
Current untreated hypertension (systolic >= 160 mmHg or diastolic >= 100 mmHg).Patients with one blood pressure reading with systolic < 160 mmHg and diastolic < 100 mmHg within 90 days of registration would be eligible for study.
Individuals with a history of another malignancy are not eligible if:
The cancer is under active treatment
The cancer can be seen on radiology scans
If they are off cancer treatment, but in the opinion of their oncologist, havea high risk of relapse within 5 years.
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to study drugs
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection (NCI-CTCAE version 5.0 Grade 2), psychiatric illness or social situationsthat would limit compliance with study requirement
Any condition that, in the opinion of the site investigator, would precludeparticipation in this study
Study Design
Study Description
Connect with a study center
Stamford Hospital
Stamford, Connecticut 06904
United StatesSite Not Available
Florida Cancer Affiliates
Panama City, Florida 32405
United StatesSite Not Available
Beth Israel Deaconness Medical Center
Boston, Massachusetts 02115
United StatesSite Not Available
Brigham and Women Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts 01757
United StatesSite Not Available
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts 02190
United StatesSite Not Available
Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63108
United StatesSite Not Available
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska 68130
United StatesSite Not Available
NYU Long Island
Garden City, New York 11530
United StatesSite Not Available
NYU Winthrop
Garden City, New York 11530
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Associated Medical Professionals of NY
Syracuse, New York 13210
United StatesSite Not Available
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