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Prostate CancerPhase 2NCT04025372

INTREPId (INTermediate Risk Erection PreservatIon Trial)

A Phase 2 study testing Bicalutamide, GnRH Agonist and Radiation Therapy in people with Prostate Cancer, run by Brigham and Women's Hospital at 11 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Bicalutamide, GnRH Agonist and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
11 sitesUnited States
Study dates
1 Jun 2020to 1 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 as clinical T2b-T2c, Gleason 7, or PSA 10-20 ng/mL. Patients who only have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded.
  • Able to characterize the number of unfavorable intermediate risk factors below:
  • 2-3 intermediate risk factors
  • T2b-T2c
  • Gleason 7
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  • 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 for processing will not be excluded. Patients who already have a Decipher score must present 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 of registration
  • 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 the usual quality of your erections during the past 4 weeks" on the EPIC-26 questionnaire
  • Agrees to use a condom and another effective method of birth control if he is having sex with a woman of childbearing potential (defined as a premenopausal female capable of becoming pregnant) OR agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. It is recommended that men who have had a vasectomy more than a year prior 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 the study as determined by the site investigator or protocol designee
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. Note: HIPAA authorization may be included in the informed consent or obtained separately. Subject must have the ability to understand and willingness to sign the written informed consent document.
  • Ability to swallow pills.
  • For patients in whom SBRT/combination RT stratification is pre-specified, prostate volume as determined by MRI, CT, or ultrasound to be less than 90 cc.

Who cannot join

  • Prior surgical, cryotherapy, or high-intensity focused ultrasound for prostate cancer
  • 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 inhibitor such as abiraterone acetate, TAK-700, or oral ketoconazole longer than 28 days
  • Prior use of estrogens; patients who have used testosterone injections must have ceased utilization within 90 days prior to screening testosterone. Patients who have used any other type of testosterone supplementation (e.g. patches) must have ceased utilization within 45 days prior to screening testosterone.
  • Use of 5-α reductase inhibitors (finasteride, dutasteride) within 28 days of randomization.
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  • Prior radiation therapy that would result in overlap of current radiation therapy fields
  • Prior chemotherapy for prostate cancer
  • Clinically positive lymph nodes by imaging, sampling, or dissection. Patients with lymph nodes greater than 1.5 cm on short axis will require a negative biopsy for eligibility.
  • Metastatic disease, as assessed by abdominal or pelvic computed tomography (CT) or other imaging modality. Patients with 3 intermediate risk factors will require a CT abdomen/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 or IV, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), clinically significant ventricular arrhythmias, moderate or severe hepatic impairment (Child Pugh Class B or C), viral hepatitis, or human immunodeficiency virus within 6 months prior 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, have a high risk of relapse within 5 years.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (NCI-CTCAE version 5.0 Grade 2), psychiatric illness or social situations that would limit compliance with study requirement
  • Any condition that, in the opinion of the site investigator, would preclude participation in this study

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Beth Israel Deaconness Medical Center

    Boston, Massachusetts, 02115

  • Brigham and Women Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • NYU Long Island

    Garden City, New York, 11530

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

    Milford, Massachusetts, 01757

  • NYU Langone Health

    New York, New York, 10016

  • XCancer Omaha / Urology Cancer Center

    Omaha, Nebraska, 68130

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

    South Weymouth, Massachusetts, 02190

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63108

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: INTREPId (INTermediate Risk Erection PreservatIon Trial): A Randomized Trial of Radiation Therapy and Darolutamide for Prostate Cancer

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.

Read the detailed 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.

Conditions
Prostate Cancer
Being tested
Bicalutamide, GnRH Agonist, Radiation Therapy, Darolutamide
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BicalutamideDrug

    Bicalutamide is categorized as an antiandrogen. Antiandrogens are substances that block the effects of testosterone. Cancer of the prostate depends on the male hormone testosterone for its growth. If the amount of testosterone is reduced it is possible to slow down or shrink the cancer.

  • GnRH AgonistDrug

    In men, GnRH agonists cause the testicles to stop making testosterone. Some GnRH agonists are used to treat prostate cancer.

  • Radiation TherapyRadiation

    Radiation Therapy is a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors.

  • DarolutamideDrug

    Darolutamide belongs to a class of drugs called androgen receptor inhibitors. In the body, these agents compete with androgens for binding to the androgen receptor, which reduces the ability of androgens to promote the growth of prostate cancer cells

Study groups in NCT04025372
Study groupRoleWhat they receive
Bicalutamide+GnRH Agonist+Radiation TherapyExperimental* Bicalutamide is administered orally on a daily basis * GnRH Agonist as prescribed * Radiation therapy is administered starting 4-16 weeks after ADT
Receives: Drug: Bicalutamide; Drug: GnRH Agonist; Radiation: Radiation Therapy
Darolutamide+Radiation TherapyExperimental* Darolutamide is administered orally twice daily * Radiation therapy is administered starting 4-16 weeks after Darolutamide
Receives: Radiation: Radiation Therapy; Drug: Darolutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of patients with a PSA nadir <= 0.5

    A response is defined as a PSA nadir <= 0.5 within 6 months from end of treatment

    Measured: 6 months from end of treatment

Secondary outcomes (13)

  1. The percentage of patients with good erectile function at 3 months from end of treatment

    Good erectile function is defined as firm enough for masturbation or foreplay' or 'firm enough for intercourse' responses to the question "How would you describe the usual quality of your erections during the past 4 weeks" on the EPIC-26 questionnaire.

    Measured: 3 months from end of treatment

  2. PSA progression free survival

    PSA progression-free survival is defined as the time from randomization to PSA progression (PSA rise of 2 ng/mL above the nadir value).

    Measured: 3 years

  3. Metastasis free survival

    Metastasis-free survival is defined as the time from randomization to distant metastasis (including bony or visceral) identified on imaging or pathologically, or death due to any cause, or censored at date last known alive.

    Measured: 3 years

  4. Cause specific survival

    Cause specific survival is defined as the interval from the date of randomization to the date of last known follow-up alive, or the date of death from each of the following causes: prostate cancer, cardiovascular disease, other causes

    Measured: 3 years

  5. To evaluate differences in long-term maintenance of erectile function

    The answers to EPIC-26 question "How would you describe the usual quality of your erections during the past 4 weeks" from treatment start to the end of follow up at three years show how erectile function has been affected over time.

    Measured: 3 years

  6. Rate of Toxicity

    Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 3 years

  7. Quality of Life impact as measured by Expanded Prostate Cancer Index (EPIC)-26

    EPIC-26 is a shortened version of the EPIC questionnaire that evaluates subject's urinary incontinence, urinary irritation/obstruction, bowel, sexual, and hormonal domains. EPIC is a robust prostate-cancer health-related QOL instrument that measures a broad spectrum of symptoms and has been widely validated. For each domain, scales range between 0 (worse) and 100 (better).

    Measured: 3 years

  8. Global health impact as measured by Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Score

    PROMIS is a standardized method for measuring an individual's global health in terms of physical and mental functioning. Scores range from 23.4 (worse) to 63.3 (better).

    Measured: 3 years

  9. Memory as measured by the St. Louis University Mental Status Examination (SLUMS)

    SLUMS is a single-page exam that measures mild cognitive changes. Scores can be divided as 0-20 (mild dementia), 21-26 (mild cognitive disorder), and 27-30 (normal).

    Measured: 3 years

  10. Quality of Life impact as measured by Patient-Reported Outcome Measurement Information System (PROMIS) Sexual Function and Satisfaction Measures (SexFS) Brief Profile Version 2.0.

    The PROMIS SexFS Brief Profile v2.0 measures a range of sexual activities, symptoms, functioning, and evaluation of experiences over the past 30 days. Scores range from 31.6 (worse) to 62.7 (better).

    Measured: 3 years

  11. Testosterone kinetics

    For arm 1, time to Testosterone Recovery is defined as the time from randomization to the date at which the testosterone level returns to a normal level on the assay used, or censored at date of last disease evaluation for those whose testosterone has not reached a normal level. Furthermore, testosterone levels will be compared between arms 1 and 2 at EOT and yearly intervals after EOT.

    Measured: 3 years

  12. Cardiovascular events

    Time to cardiovascular event is defined as the time from randomization to the date at which the first cardiovascular event occurs. Censoring occurs at date of last disease evaluation for those who did not have a cardiovascular event. Cardiovascular events consisting of myocardial infarction, stroke, deep venous thrombosis, or pulmonary embolism will be collected during study visits and follow-ups.

    Measured: 3 years

  13. Time to re-initiation of ADT

    Time to re-initiation of ADT is defined as the time from randomization to the date at which ADT is reinitiated. Censoring occurs at date of last disease evaluation for those who are not restarted on ADT.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start1 Jun 2020
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025372
Sponsor's protocol ID
19-202
Status last verified
Dec 2025
First submitted
16 Jul 2019
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Publications

  • Roy A, Green O, Brenneman R, Bosch W, Gay HA, Michalski JM, Baumann BC. Assessing Inter-Fraction Changes in The Size and Position of The Penile Bulb During Daily MR-Guided Radiation Therapy to The Prostate Bed: Do We Need to Adjust How We Plan Radiation in The Post-Radical Prostatectomy Setting to Reduce Risk of Erectile Dysfunction? Clin Genitourin Cancer. 2022 Jun;20(3):e227-e232. doi: 10.1016/j.clgc.2022.01.006. Epub 2022 Jan 11.

    PubMed 35153154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bicalutamide, GnRH Agonist and Radiation Therapy in people with Prostate Cancer, run by Brigham and Women's Hospital at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of patients with a PSA nadir <= 0.5 (time frame: 6 months from end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04025372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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Clinical Trial NCT04025372 | AzTrials