The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared to LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The endpoints selected reflect measurable short term effects of androgen deprivation therapy (ADT), including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer|
- Mean change in quality of life (QOL) measured by total FACT-P score [ Time Frame: 12 months ] [ Designated as safety issue: No ]To compare the mean change in QOL as measured by total FACT-P score after 12 months of therapy with ARN-509 monotherapy and ARN-509 + LHRHa versus LHRHa monotherapy, in men with biochemically relapsed prostate cancer.
- Quality of Life Instruments [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]To compare ARN-509 monotherapy and ARN-509 + LHRHa vs. LHRHa monotherapy with regards to the mean change in QOL at 24 months as measured by FACT-P, EORTC QLQ-C30/PR-25 and the SHIM scale.
- PSA Modulation [ Time Frame: Approx. 7-24 months ] [ Designated as safety issue: No ]To compare ARN-509 monotherapy and ARN-509 + LHRHa vs. LHRHa monotherapy with regards to the proportion of patients who demonstrate testosterone recovery without evidence of PSA or radiographic progression at 24 months, the proportion of patients with a nadir PSA <0.2 ng/mL after 7 months, and the time to PSA progression.
- Metabolic and Hormonal Changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]To compare ARN-509 monotherapy and ARN-509 + LHRHa vs. LHRHa monotherapy with regards to the mean change in baseline in markers of insulin resistance, fasting lipid profile, bone mineral density, serum DHT, and estradiol levels after 12 months, and the time to serum testosterone recovery to >50 ng/dL and >150 ng/dL after cessation of protocol therapy for 12 months.
- Toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]To characterize the safety profile of ARN-509 alone and in combinations with a LHRHa based on CTCAE v4.0.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Active Comparator: ARN-509
ARN-509 Softgel Capsules, 240 mg/day administered orally
Active Comparator: LHRH agonist + ARN-509
Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Softgel Capsules, 240 mg/day administered orally
Drug: LHRH Agonist
Active Comparator: LHRH agonist
Choice of LHRHa per investigator discretion/site practice guidelines (e.g., Eligard®, Zoladex®, Lupron Depot®, Trelstar®).
Drug: LHRH Agonist
|United States, California|
|University of California San Francisco (UCSF) Medical Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Kimberly Lowe 415-885-7383 firstname.lastname@example.org|
|Principal Investigator: Terence Friedlander, MD|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Amanda Krug 773-702-2290 email@example.com|
|Principal Investigator: Russell Szmulewitz, MD|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Seonaid Squires 503-418-9104 firstname.lastname@example.org|
|Principal Investigator: Joshi Alumkal, MD|
|United States, Washington|
|Seattle Cancer Care Alliance/University of Washington||Recruiting|
|Seatlle, Washington, United States, 98109|
|Contact: Angela Uzun 206-288-1349 email@example.com|
|Principal Investigator: Celestia Higano, MD|
|Study Director:||Edna Chow Maneval, PhD||Aragon Pharmaceuticals|