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A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02499497
Recruitment Status : Recruiting
First Posted : July 16, 2015
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Shalender Bhasin, MD, Dana-Farber Cancer Institute

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


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: LY2452473 Drug: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Actual Study Start Date : February 29, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose I or LY SARM Dose 2 daily, oral per cycle.
Drug: Placebo
The participants will receive pills containing no active drug.
Other Name: Inactive comparator

Active Comparator: LY2452473 Dose I
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY2452473 Dose I or LY2452473 Dose 2 daily, oral per cycle.
Drug: LY2452473
LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Other Name: Selective Androgen Receptor Modulator

Active Comparator: LY2452473 Dose 2
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY2452473 Dose I or LY SARM Dose 2 daily, oral per cycle.
Drug: LY2452473
LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Other Name: Selective Androgen Receptor Modulator




Primary Outcome Measures :
  1. Harbor-UCLA 7-day Sexual Function Questionnaire [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. disease-specific quality of life questionnaire [ Time Frame: 6 Months ]
    HRQOL

  2. Fatigue The Functional Assessment of Chronic Illness Therapy (FACIT -1) Fatigue Scale [ Time Frame: 6 Months ]
  3. Lean body mass using DXA [ Time Frame: 6 months ]
  4. Number of participants with Adverse Events [ Time Frame: 6 months ]
  5. muscle strength [ Time Frame: 6 months ]
    The one-repetition maximum (1RM) test

  6. Continuous Scale Physical Functional Performance 10 [ Time Frame: 6 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

    • Stage pT2 N0, M0 lesions (If 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 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 LC-MS/MS, <300 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL.

    * 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, DHEA, estrogens, GnRH analogs, antiandrogens, spironolactone,ketoconazole, rhGH, or megesterol 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
  • AST greater than 3x ULN
  • 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 CPAP, BiPAP, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499497


Contacts
Contact: Shalender Bhasin, MD 617-525-9040 sbhasin@partners.org

Locations
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Megan Roberts, MS    352-294-5090    Mlorow@ufl.edu   
Principal Investigator: Marco Pahor, MD         
United States, Maryland
John Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Arthur Burnett, MD         
Principal Investigator: Arthur Burnett, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center (Referring site only) Recruiting
Boston, Massachusetts, United States, 02115
Contact: Catrina Crociani       ccrocian@bidmc.harvard.edu   
Principal Investigator: Peter Chang, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Shalender Bhasin, MD    617-525-9040    sbhasin@partners.org   
Principal Investigator: Shalender Bhasin, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Shalender Bhasin, MD Brigham and Women's Hospital

Responsible Party: Shalender Bhasin, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02499497     History of Changes
Other Study ID Numbers: 15-120
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Keywords provided by Shalender Bhasin, MD, Dana-Farber Cancer Institute:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs