A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

NCT02499497 | Completed Phase 2 Results DMC

• 1 other identifier: 15-120
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 4

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)

  The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity.

  12 weeks from baseline

Secondary Outcomes (33)

• Change in All Domains of International Index of Erectile Function (IIEF)

  12 weeks from baseline

• Change in Sexual Activity, Interest, and Desire Scale (SAID)

  12 weeks from baseline

• Change in Derogatis Index of Sexual Function Male II (DISF-M-II)

  12 weeks from baseline

• Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)

  12 weeks from baseline

• Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)

  12 weeks from baseline

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

LY2452473 Dose 1

ACTIVE COMPARATOR

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.

Drug: LY2452473

LY2452473 Dose 2

ACTIVE COMPARATOR

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.

Drug: LY2452473

LY2452473 Dose 3

ACTIVE COMPARATOR

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.

Drug: LY2452473

Interventions

LY2452473 DRUG

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

Also known as: Selective Androgen Receptor Modulator

LY2452473 Dose 1; LY2452473 Dose 2; LY2452473 Dose 3

Placebo DRUG

The participants will receive pills containing no active drug.

Also known as: Inactive comparator

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (4)

University of Florida

Gainesville, Florida, 32611, United States

Location

John Hopkins Medical Center

Baltimore, Maryland, 21231, United States

Location

Beth Israel Deaconess Medical Center (Referring site only)

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 34019661 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

LY2452473

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Shalender Bhasin, Principal Investigator
• Organization: Brigham and Women's hospital

sbhasin@bwh.harvard.edu

617 525 9150

Study Officials

• Shalender Bhasin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 16, 2015
• Study Start: February 29, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-09

Locations

US (4)