Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer
Study Details
Study Description
Brief Summary
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 |
|---|---|---|
| Phase 2 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neoadjuvant apalutamide Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection |
Drug: Apalutamide
Participants will receive oral apalutamide 240mg daily for 12 weeks
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy [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 [24 weeks]
Patients who attain serum PSA levels below 0.03microg/L
Secondary Outcome Measures
- Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide [12 weeks]
Adverse effects as defined by CTCAE criteria grade 3 and above
- The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy [24 weeks]
The level of complications defined by Clavien-Dindo classification
Eligibility Criteria
Criteria
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:
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presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
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individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
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patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
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renal impairment with serum creatinine more than twice the upper limit of normal
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Other prior malignancy less than or equal to 5 years prior to recruitment
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ECOG performance status 2 or poorer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Urology | Singapore | Singapore | 169608 |
Sponsors and Collaborators
- Singapore General Hospital
Investigators
- Principal Investigator: Lui Shiong Lee, MBBS,MRCS, Singapore General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARN509 - 2016