Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03124433|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : April 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Prostate||Drug: Apalutamide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Neoadjuvant apalutamide
Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection
Participants will receive oral apalutamide 240mg daily for 12 weeks
Other Name: ARN509
- Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy [ Time Frame: 24 weeks ]This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy
- Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy [ Time Frame: 24 weeks ]Patients who attain serum PSA levels below 0.03microg/L
- Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide [ Time Frame: 12 weeks ]Adverse effects as defined by CTCAE criteria grade 3 and above
- Proportion of tumour and benign cells with androgen receptor localisation in the cytoplasm and nucleus [ Time Frame: 16 weeks ]To ascertain the eAR intra-cellular localisation after neoadjuvant apalutamide therapy
- The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy [ Time Frame: 24 weeks ]The level of complications defined by Clavien-Dindo classification
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124433
|Department of Urology|
|Singapore, Singapore, 169608|
|Principal Investigator:||Lui Shiong Lee, MBBS,MRCS||Singapore General Hospital|