INTREPId (INTermediate Risk Erection PreservatIon Trial)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2027
  • participants needed
    220
  • sponsor
    Dana-Farber Cancer Institute
Updated on 12 June 2021
platelet count
gonadotropin
endocrine therapy
testosterone
neutrophil count
hormone therapy
bicalutamide
luteinizing hormone-releasing hormone agonist
adenocarcinoma
adenocarcinoma of prostate
gonadorelin

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.

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment bicalutamide, radiation therapy, GnRH agonist, Darolutamide
Clinical Study IdentifierNCT04025372
SponsorDana-Farber Cancer Institute
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

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 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
Successful acquisition of a genomic classifier Decipher score from archived tissue. Patients who already have a Decipher score must present official documentation of the report
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/ L
Hemoglobin (Hgb) 9 g/dL
Absolute neutrophil count (ANC) 1000 cells/L
Renal
\--Glomerular filtration rate (GFR) 45 mL/min
Hepatic and Other
Bilirubin 1.5 upper limit of normal (ULN)
Aspartate aminotransferase (AST) 2.5 ULN
Alanine aminotransferase (ALT) 2.5 ULN
Serum Albumin > 3.0 g/dL
Serum potassium 3.5 mmol/L
Coagulation
International Normalized Ratio (INR)
or Prothrombin Time (PT)
Activated Partial Thromboplastin Time
(aPTT) 1.5 ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin)
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
Testosterone 190 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

Exclusion Criteria

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 use of estrogens; patients who have used testosterone supplementation (patches, injections, etc.) must have ceased utilization within 90 days prior to randomization
Prior treatment with other investigational AR inhibitors, CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700, or oral ketoconazole longer than 28 days
Use of 5- 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
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
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
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
Current untreated hypertension (systolic >= 160 mmHg or diastolic >= 100 mmHg)
Erectile aids other than oral phosphodiesterase (PDE)-5 inhibitors
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
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