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

NCT01790126 | Completed Phase 2 Results

• 2 other identifiers: CR103305ARN-509-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief Summary

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 with 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.

Conditions

Prostate Cancer

Keywords

Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score at 12 Months

  FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACT-General (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.

  Baseline, at 12 months

Secondary Outcomes (16)

• Change From Baseline in FACT-P Total Score at 3 and 24 Months

  Baseline, at 3 and 24 months

• Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score at 3, 12 and 24 Months

  Baseline, at 3, 12 and 24 months

• Change From Baseline in EORTC Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Score at 3, 12 and 24 Months

  Baseline, at 3, 12 and 24 months

• Change From Baseline in Sexual Health Inventory for Men (SHIM) Total Score at 3, 12, 24 Months

  Baseline, at 3, 12, 24 months

• Time to Prostate Specific Antigen (PSA) Progression Based on Modified Prostate Cancer Clinical Trials Working Group (PCWG2) Criteria

  Up to 24 months

Study Arms (3)

ARN-509

ACTIVE COMPARATOR

ARN-509 Tablets, 240 mg/day administered orally

Drug: ARN-509

LHRH agonist + ARN-509

ACTIVE COMPARATOR

Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally

Drug: ARN-509; Drug: LHRH Agonist

LHRH agonist

ACTIVE COMPARATOR

Choice of LHRHa per investigator discretion/site practice guidelines (e.g., Eligard®, Zoladex®, Lupron Depot®, Trelstar®).

Drug: LHRH Agonist

Interventions

ARN-509 DRUG

ARN-509; LHRH agonist + ARN-509

LHRH Agonist DRUG

Also known as: Eligard®, Lupron Depot®, Zoladex®, Trelstar®

LHRH agonist; LHRH agonist + ARN-509

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 on imaging by whole body bone scan and computerized tomography (CT) or Magnetic Resonance Imaging (MRI) of the abdomen/pelvis within 6 weeks prior to randomization
• 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
• Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (\>) 6 months prior to randomization
• 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

You may not qualify if:

• Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks prior to randomization
• Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to randomization
• Prior bilateral orchiectomy
• Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of ADT is greater than (\>) 6 months prior to randomization and the Screening serum testosterone level is greater than or equal to (≥)150 ng/dL
• Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization
• Any history of seizures or medical condition which lowers seizure threshold

Sponsors & Collaborators

• Aragon Pharmaceuticals, Inc.: lead

Study Sites (5)

Unknown Facility

Scottsdale, Arizona, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Gonadotropin-Releasing Hormone; luprolide acetate gel depot; Leuprolide; Goserelin; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: EXECUTIVE MEDICAL DIRECTOR
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Aragon Pharmaceuticals, Inc Clinical Trial

  Aragon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 13, 2013
• Study Start: March 4, 2013
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-02

Locations

US (5)