INTREPId (INTermediate Risk Erection PreservatIon Trial)

Last updated: April 7, 2025
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Not Recruiting

Phase

2

Condition

Prostate Cancer, Early, Recurrent

Urologic Cancer

Prostate Cancer

Treatment

Bicalutamide

Darolutamide

Radiation Therapy

Clinical Study ID

NCT04025372
19-202
  • Ages > 18
  • Male

Study Summary

This research study is comparing the use of a new form of hormonal therapy used with radiation as a possible treatment for intermediate risk prostate cancer. More specifically, this research would help determine whether this new form of hormonal therapy is as effective as the standard hormone therapy while also preserving erectile function.

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

Total Participants: 234
Treatment Group(s): 4
Primary Treatment: Bicalutamide
Phase: 2
Study Start date:
June 01, 2020
Estimated Completion Date:
March 01, 2028

Study Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

In this research study, the investigators are looking at whether the novel form of hormonal therapy, called Darolutamide, when paired with radiation therapy will provide the same quality of care as the current standard treatments available for men with this type of cancer. Darolutamide prevents testosterone from signaling throughout the body. Although studies have shown that Darolutamide has activity in more advanced forms of prostate cancer, the activity of Darolutamide is unknown in intermediate risk prostate cancer treated with radiation therapy. The U.S. Food and Drug Administration (FDA) has not approved Darolutamide as a treatment for any disease.

The current standard of care treatments available to men with this type of cancer are radiation therapy with or without androgen deprivation therapy (ADT) involving a gonadotropin releasing hormone agonist plus bicalutamide (both FDA-approved) or surgery. ADT works by depriving the body of testosterone which "feeds" prostate cancer cells and weakens prostate cancer cells from repairing damage caused by radiation therapy.

In addition, the investigator will be assessing erectile function at baseline, during and after treatment to determine if short-term erectile function can be preserved without sacrificing long-term disease control.

Connect with a study center

  • Stamford Hospital

    Stamford, Connecticut 06904
    United States

    Site Not Available

  • Florida Cancer Affiliates

    Panama City, Florida 32405
    United States

    Site Not Available

  • Beth Israel Deaconness Medical Center

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center

    Milford, Massachusetts 01757
    United States

    Site Not Available

  • Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital

    South Weymouth, Massachusetts 02190
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • XCancer Omaha / Urology Cancer Center

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • NYU Long Island

    Garden City, New York 11530
    United States

    Site Not Available

  • NYU Winthrop

    Garden City, New York 11530
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Associated Medical Professionals of NY

    Syracuse, New York 13210
    United States

    Site Not Available

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