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History of Changes for Study: NCT02499497
A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Latest version (submitted November 9, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 15, 2015 None (earliest Version on record)
2 January 9, 2017 Recruitment Status, Study Status and Contacts/Locations
3 March 21, 2017 Study Status and Eligibility
4 May 23, 2017 Study Status and Contacts/Locations
5 January 30, 2018 Study Status
6 July 24, 2018 Contacts/Locations, Study Status and Study Design
7 April 3, 2019 Study Status and Study Design
8 November 5, 2019 Recruitment Status, Study Status, Contacts/Locations, Eligibility and Study Design
9 March 4, 2020 Recruitment Status and Study Status
10 November 5, 2020 Study Status
11 November 9, 2020 Study Status
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Study NCT02499497
Submitted Date:  November 5, 2019 (v8)

Study Identification
Unique Protocol ID: 15-120
Brief Title: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Official Title: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Secondary IDs:
Study Status
Record Verification: November 2019
Overall Status: Active, not recruiting
Study Start: February 29, 2016
Primary Completion: December 31, 2019 [Anticipated]
Study Completion: November 2022 [Anticipated]
First Submitted: July 6, 2015
First Submitted that
Met QC Criteria:
July 15, 2015
First Posted: July 16, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 5, 2019
Last Update Posted: November 6, 2019 [Actual]
Sponsor/Collaborators
Sponsor: Dana-Farber Cancer Institute
Responsible Party: Principal Investigator
Investigator: Shalender Bhasin, MD
Official Title: Principal Investigator
Affiliation: Dana-Farber Cancer Institute
Collaborators: National Institute of Nursing Research (NINR)
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Study Description
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
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 114 [Actual]
Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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 Names:
  • 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 Names:
  • Selective Androgen Receptor Modulator
Outcome Measures
Primary Outcome Measures:
1. Harbor-UCLA 7-day Sexual Function Questionnaire
6 Months
Secondary Outcome Measures:
2. disease-specific quality of life questionnaire
HRQOL

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

[Time Frame: 6 months]
7. Continuous Scale Physical Functional Performance 10
6 months
Eligibility
Minimum Age: 19 Years
Maximum Age:
Sex: Male
Gender Based:
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 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
  • 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
Contacts/Locations
Study Officials: Shalender Bhasin, MD
Principal Investigator
Brigham and Women's Hospital
Locations: United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Maryland
John Hopkins Medical Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center (Referring site only)
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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