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 July 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: July 28, 2014
Last verified: July 2014

February 8, 2013
July 28, 2014
March 2013
February 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01790126 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: ARN-509
  • Drug: LHRH Agonist
    Other Names:
    • Eligard®
    • Lupron Depot®
    • Zoladex®
    • Trelstar®
  • Active Comparator: ARN-509
    ARN-509 Softgel Capsules, 240 mg/day administered orally
    Intervention: 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
    Interventions:
    • Drug: ARN-509
    • Drug: LHRH Agonist
  • Active Comparator: LHRH agonist
    Choice of LHRHa per investigator discretion/site practice guidelines (e.g., Eligard®, Zoladex®, Lupron Depot®, Trelstar®).
    Intervention: Drug: LHRH Agonist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
February 2018
February 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
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
United States
 
NCT01790126
CR103305, ARN-509-002
No
Aragon Pharmaceuticals, Inc.
Aragon Pharmaceuticals, Inc.
Not Provided
Study Director: Aragon Pharmaceuticals, Inc Clinical Trial Aragon Pharmaceuticals, Inc.
Aragon Pharmaceuticals, Inc.
July 2014

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