The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Aragon Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01790126
First received: February 8, 2013
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: ARN-509
Drug: LHRH Agonist
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Aragon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARN-509
ARN-509 Softgel Capsules, 240 mg/day administered orally
Drug: ARN-509
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: ARN-509 Drug: LHRH Agonist
Other Names:
  • Eligard®
  • Lupron Depot®
  • Zoladex®
  • Trelstar®
Active Comparator: LHRH agonist
Choice of LHRHa per investigator discretion/site practice guidelines (e.g., Eligard®, Zoladex®, Lupron Depot®, Trelstar®).
Drug: LHRH Agonist
Other Names:
  • Eligard®
  • Lupron Depot®
  • Zoladex®
  • Trelstar®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate
  • Rising PSA after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy with curative intent
  • PSA doubling time less than or equal to 12 months
  • No evidence of metastatic disease by CT/MRI abdomen/pelvis and whole body bone scan
  • Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy
  • No androgen deprivation therapy or anti-androgen (i.e. bicalutamide) within 12 months of study entry
  • No prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapse
  • Serum testosterone > 150 ng/dL at study entry
  • No history of seizures or medical conditions which may lower seizure threshold

Key Exclusion Criteria:

  • Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 3 months of study entry
  • Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 12 months of study entry
  • Prior bilateral orchiectomy
  • Prior hormonal treatment with ADT or antiandrogen for biochemically relapsed prostate cancer
  • Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at the time of study entry
  • Any history of seizures or medical condition which lowers seizure threshold
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790126

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States
United States, California
Recruiting
San Francisco, California, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Washington
Recruiting
Seattle, Washington, United States
Sponsors and Collaborators
Aragon Pharmaceuticals, Inc.
Investigators
Study Director: Aragon Pharmaceuticals, Inc Clinical Trial Aragon Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01790126     History of Changes
Other Study ID Numbers: CR103305, ARN-509-002
Study First Received: February 8, 2013
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aragon Pharmaceuticals, Inc.:
Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Hormones
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014