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 February 2015 by Aragon Pharmaceuticals, Inc.
Sponsor:
Aragon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01790126
First received: February 8, 2013
Last updated: February 3, 2015
Last verified: February 2015
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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:
|
|
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:
|
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
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: | February 3, 2015 |
| 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 |
ClinicalTrials.gov processed this record on March 03, 2015