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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20111930

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