Phase 2
N=114
A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02499497 ↗Enrolled (actual)
114
Serious AEs
5.3%
Results posted
Sep 2021
Primary outcome: Primary: Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) — 0.04; 0.45; -0.02; 0.12 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2452473 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) |
0.04; 0.45; -0.02; 0.12 | — |
| SECONDARY Change in All Domains of International Index of Erectile Function (IIEF) |
2.34; 0.92; -0.50; 3.38; 0.97; 0.42 | — |
| SECONDARY Change in Sexual Activity, Interest, and Desire Scale (SAID) |
-0.67; 4.25; -3.00; -1.50 | — |
| SECONDARY Change in Derogatis Index of Sexual Function Male II (DISF-M-II) |
-0.88; 0.87; -0.81; 1.08; 0.45; 0.83 | — |
| SECONDARY Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ) |
0.80; 0.80; -0.65; 1.30; 1.34; 2.38 | — |
| SECONDARY Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC) |
1.86; 3.68; 0.08; 5.77; 1.24; 0.44 | — |
| SECONDARY Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale |
0.31; 2.29; -0.36; 0.26 | — |
| SECONDARY Change in Hypogonadism Energy Diary (HED) |
-0.45; 2.71; 2.64; 1.73 | — |
| SECONDARY Change in International Prostate Symptom Score (IPSS) |
-0.30; -2.08; 0.06; 0.00; -0.13; -0.17 | — |
| SECONDARY Change in Positive and Negative Affect Scale (PANAS) |
0.91; 0.75; 1.42; -0.77; -1.70; -1.38 | — |
| SECONDARY Change in Body Mass Using DXA |
-0.06; -0.19; -0.36; -0.13; -0.00; -0.32 | — |
| SECONDARY Change of Maximal Voluntary Muscle Strength |
-12.6; 108.1; 48.1; 103.5 | — |
| SECONDARY Change in Gait Speed in 6-minute Walk |
0.05; 0.07; 0.08; 0.05 | — |
| SECONDARY Change of 50 Meters Walk Tests- Unloaded /Loaded |
0.06; 0.12; 0.03; 0.07; 0.05; 0.13 | — |
| SECONDARY Change in Power of Stair Climbing Tests- Unloaded/Loaded |
12.8; 19.7; 1.8; 51.7; 0.22; -36.6 | — |
| SECONDARY Change in Serum Total Testosterone Level |
-6.5; -83.5; -172.3; -185.2 | — |
| SECONDARY Change in Free Testosterone Level |
0.19; 0.59; 1.43; 1.62 | — |
| SECONDARY Change in Serum Sex Hormone-binding Globulin (SHBG) Level |
0.6; -9.6; -21.7; -24.2 | — |
| SECONDARY Change in Serum Luteinizing Hormone (LH) Level |
0.23; 0.11; 0.72; -0.42 | — |
| SECONDARY Change in Estradiol Levels |
-0.2; -1.1; -5.5; -7.9 | — |
| SECONDARY Change of White Blood Cell |
-0.24; 0.30; -0.21; 0.32 | — |
| SECONDARY Change of Red Blood Cell |
-0.08; -0.05; 0.03; 0.06 | — |
| SECONDARY Change in Hematocrit |
-0.61; -0.30; 0.44; 0.11 | — |
| SECONDARY Change in Hemoglobin |
-0.32; -0.12; 0.09; -0.01 | — |
| SECONDARY Change of Mean Corpuscular Volume (MCV) |
0.32; 0.44; 0.37; -1.08 | — |
| SECONDARY Change of Red Blood Cell Distribution Width (RDW) |
0.09; -0.15; 0.18; -0.44 | — |
| SECONDARY Change in Platelet Count |
0.67; 6.54; 13.5; 28.7 | — |
| SECONDARY Change of Aspartate Aminotransferase (AST) |
-1.24; -1.25; 2.33; 4.46 | — |
| SECONDARY Change of Alanine Aminotransferase (ALT) |
-1.36; -3.46; 1.28; 5.46 | — |
| SECONDARY Change of Total Bilirubin |
-0.13; -0.02; -0.16; -0.18 | — |
| SECONDARY Change in Serum Alkaline Phosphatase |
-2.94; -2.83; -8.97; -14.1 | — |
| SECONDARY Change of Lipid Panel |
-7.55; -15.1; -13.4; -14.9; -2.55; -4.38 | — |
| SECONDARY Change in Fasting Glucose Levels |
0.33; 0.04; -2.78; -8.54 | — |
| SECONDARY Change in Insulin |
-0.17; 0.36; -1.63; -1.00 | — |
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
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 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
Data sourced from ClinicalTrials.gov (NCT02499497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.