Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-08-22

Brief Summary

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This is an investigator-initiated phase II single arm trial, combining neoadjuvant apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate resistant prostate cancer in phase II studies and are now in phase III trials combined with radiation in organ confined disease.

The primary study objectives include assessment of (i) oncological efficacy as determined by tumour downstaging and achievement of nadir PSA The secondary study objectives include(i) determination of adverse effects related to apalutamide and surgical complication rates (ii) human prostate tissue effect of apalutamide

The study will recruit thirty eligible participants who will receive 12 weeks of oral apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The total trial duration is 26 weeks.

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Detailed Description

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This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases.

Safety will be monitored throughout the study.

Conditions

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Cancer of the Prostate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant apalutamide

Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection

Group Type EXPERIMENTAL

Apalutamide

Intervention Type DRUG

Participants will receive oral apalutamide 240mg daily for 12 weeks

Interventions

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Apalutamide

Participants will receive oral apalutamide 240mg daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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ARN509

Eligibility Criteria

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Inclusion Criteria

* histologically diagnosed primary adenocarcinoma of the prostate gland
* non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy
* no known hypersensitivity to the study drug
* able to swallow study drug as whole tablets

Exclusion Criteria

* presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
* individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
* patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
* renal impairment with serum creatinine more than twice the upper limit of normal
* Other prior malignancy less than or equal to 5 years prior to recruitment
* ECOG performance status 2 or poorer

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No