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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study closed to enrollment

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

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