INTREPId (INTermediate Risk Erection PreservatIon Trial)
1 other identifier
interventional
234
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jun 2020
Longer than P75 for phase_2 prostate-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2019
CompletedFirst Posted
Study publicly available on registry
July 18, 2019
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
December 15, 2025
December 1, 2025
7.3 years
July 16, 2019
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
6 months from end of treatment
Secondary Outcomes (13)
The percentage of patients with good erectile function at 3 months from end of treatment
3 months from end of treatment
PSA progression free survival
3 years
Metastasis free survival
3 years
Cause specific survival
3 years
To evaluate differences in long-term maintenance of erectile function
3 years
- +8 more secondary outcomes
Study Arms (2)
Bicalutamide+GnRH Agonist+Radiation Therapy
EXPERIMENTAL* Bicalutamide is administered orally on a daily basis * GnRH Agonist as prescribed * Radiation therapy is administered starting 4-16 weeks after ADT
Darolutamide+Radiation Therapy
EXPERIMENTAL* Darolutamide is administered orally twice daily * Radiation therapy is administered starting 4-16 weeks after Darolutamide
Interventions
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.
In men, GnRH agonists cause the testicles to stop making testosterone. Some GnRH agonists are used to treat prostate cancer.
Radiation Therapy is a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors.
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
Eligibility Criteria
You may qualify if:
- 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:
- 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 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:
- +22 more criteria
You may not qualify if:
- 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.
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Bayercollaborator
- Decipher Biosciencescollaborator
Study Sites (11)
Stamford Hospital
Stamford, Connecticut, 06904, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02115, United States
Brigham and Women Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63108, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130, United States
NYU Long Island
Garden City, New York, 11530, United States
NYU Langone Health
New York, New York, 10016, United States
Associated Medical Professionals of NY
Syracuse, New York, 13210, United States
Related Publications (1)
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.
PMID: 35153154DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin T. King, MD, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 16, 2019
First Posted
July 18, 2019
Study Start
June 1, 2020
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Boston Children's Hospital (BCH) - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email tido@childrens.harvard.edu Beth Israel Deaconess Medical Center (BIDMC) - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu Brigham and Women's Hospital (BWH) - Contact the Partners Innovations team at http://www.partners.org/innovation Dana-Farber Cancer Institute (DFCI) - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu Massachusetts General Hospital (MGH) - Contact the Partners Innovations team at http://www.partners.org/innovation
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