A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

NCT ID: NCT02499497

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-10-31

Brief Summary

This research study is studying the use of a targeted therapy called LY SARM, which is an investigational drug from a new class of molecules called Selective Androgen Receptor Modulators (SARMs) as a possible improvement in quality of life for participants who have undergone radical prostatectomy. Androgens are a group of hormones that play a role in male traits and reproductive activity.

The names of the study interventions involved in this study are:

• LY2452473

Detailed Description

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

The FDA (the U.S. Food and Drug Administration) has not approved LY SARM/LY2452473 as a treatment for any disease.

In this research study, the investigators are studying a new investigational drug called LY SARM (LY2452473). Concerns about the potential adverse effects of testosterone on the prostate have led to the development of molecules called SARMs (Selective Androgen Receptor Modulators). This investigational drug may improve sexual function, quality of life, muscle and bone mass in men with prostate cancer. This molecule was chosen because there is some evidence that shows it may help to improve sexual function and aid in the improvement of muscle mass while not having any influence on the prostate.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The participants will receive pills containing no active drug.

LY2452473 Dose 1

Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.

Group Type: ACTIVE_COMPARATOR

LY2452473

Intervention Type: DRUG

LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.

LY2452473 Dose 2

Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1 or LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.

Group Type: ACTIVE_COMPARATOR

LY2452473

Intervention Type: DRUG

LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.

LY2452473 Dose 3

Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.

Group Type: ACTIVE_COMPARATOR

LY2452473

Intervention Type: DRUG

LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.

Interventions

LY2452473

LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.

Intervention Type: DRUG

Placebo

The participants will receive pills containing no active drug.

Intervention Type: DRUG

Other Intervention Names

Selective Androgen Receptor Modulator; Inactive comparator

Eligibility Criteria

Inclusion Criteria

• Age 19 years of age or older
• History of prostate cancer

• Stage pathological tumor-2 (pT2) N0, M0 lesions (If American Joint Committee on Cancer (AJCC) staging is not available in medical records, the investigators will infer the staging based on extensive review of the pathology report)
• Combined Gleason score < 7 (3+4)
• Radical prostatectomy two or more years ago
• Preoperative prostate-specific antigen (PSA)<10 ng/ml (if pre-operative PSA is not available in medical records, low-risk subjects with a Gleason score of 6(3+3) and who are at least 5 years out of surgery will be considered for enrollment)
• PSA <0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL for at least two years after radical prostatectomy
• Serum testosterone, measured by Liquid chromatography-tandem mass spectrometry (LC-MS/MS), <300 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL.

• Derogatis Index of Sexual Function Male II (DISF-M-II) score ≤20, fatigue (FACIT-F score <30), or physical dysfunction (self-reported difficulty in walking a 1/4 mile or climbing two flights of stairs, short physical performance battery score 4 to 9).
• Ability to understand and the willingness to sign a written informed consent document.

• Agree to use adequate contraception prior to receiving the study drug, for the duration of study participation, and 4 months after completion of LY SARM administration.

Exclusion Criteria

• History of radiation monotherapy
• History of androgen deprivation therapy
• Use of testosterone, dehydroepiandrosterone (DHEA), estrogens, gonadotropin-releasing hormone (GnRH) analogs, antiandrogens, spironolactone, ketoconazole, recombinant human growth hormone (rhGH), or megestrol acetate within the past 6 months
• Use of prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks within the past 6 months
• Use of Clarithromycin, telithromycin, chloramphenicol, itraconazole, nefazodone, cobicistat within the past 6 months
• Use of penile implants, vacuum pump devices, intra-cavernosal injections
• Hematocrit >50%
• Serum creatinine >2.5 mg/dL
• Aspartate aminotransferase (AST) greater than 3x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) greater than 3x ULN
• Hemoglobin A1c >7.5%
• Body mass index (BMI) >40 kg/m2
• Diabetes requiring insulin therapy
• Severe untreated sleep apnea (treatment is defined as therapy with continuous positive airway pressure (CPAP), BiPAP, adaptive servo-ventilation (ASV), or other positive air pressure device)
• Uncontrolled heart failure (NYHA class 3 or 4)
• History of HIV
• Myocardial infarction within the last 3 months
• Acute coronary syndrome within the last 3 months
• Revascularization surgery within the last 3 months
• Stroke within the last 3 months
• Diagnosed schizophrenia or bipolar disorder or untreated depression
• Not appropriate for study based on physician discretion

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Shalender Bhasin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shalender Bhasin, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

University of Florida

Gainesville, Florida, United States

John Hopkins Medical Center

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center (Referring site only)

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Pencina KM, Burnett AL, Storer TW, Guo W, Li Z, Kibel AS, Huang G, Blouin M, Berry DL, Basaria S, Bhasin S. A Selective Androgen Receptor Modulator (OPK-88004) in Prostate Cancer Survivors: A Randomized Trial. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2171-2186. doi: 10.1210/clinem/dgab361.

Reference Type: DERIVED

PMID: 34019661 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-120

Identifier Type: -

Identifier Source: org_study_id