Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02499497
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Shalender Bhasin, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE February 29, 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
Harbor-UCLA 7-day Sexual Function Questionnaire [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02499497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • disease-specific quality of life questionnaire [ Time Frame: 6 Months ]
    HRQOL
  • Fatigue The Functional Assessment of Chronic Illness Therapy (FACIT -1) Fatigue Scale [ Time Frame: 6 Months ]
  • Lean body mass using DXA [ Time Frame: 6 months ]
  • Number of participants with Adverse Events [ Time Frame: 6 months ]
  • muscle strength [ Time Frame: 6 months ]
    The one-repetition maximum (1RM) test
  • Continuous Scale Physical Functional Performance 10 [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Official Title  ICMJE A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
  • Drug: Placebo
    The participants will receive pills containing no active drug.
    Other Name: Inactive comparator
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: LY2452473
  • 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.
    Intervention: Drug: LY2452473
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 3, 2019)
114
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
350
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02499497
Other Study ID Numbers  ICMJE 15-120
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shalender Bhasin, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Shalender Bhasin, MD Brigham and Women's Hospital
PRS Account Dana-Farber Cancer Institute
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP