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

Primary Purpose

Cancer of the Prostate

Status

Completed

Phase

Phase 2

Locations

Singapore

Study Type

Interventional

Intervention

Apalutamide

About this trial

This is an interventional treatment trial for Cancer of the Prostate focused on measuring prostate cancer, prostatectomy, retropubic, Androgen Receptor Antagonists

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Urology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant apalutamide

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy

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

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

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

The level of complications defined by Clavien-Dindo classification

Full Information

NCT ID

NCT03124433

First Posted

April 9, 2017

Last Updated

March 17, 2020

Sponsor

Singapore General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03124433

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

June 20, 2017 (Actual)

Primary Completion Date

August 22, 2019 (Actual)

Study Completion Date

August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Prostate

Keywords

prostate cancer, prostatectomy, retropubic, Androgen Receptor Antagonists

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant apalutamide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Apalutamide

Other Intervention Name(s)

ARN509

Intervention Description

Participants will receive oral apalutamide 240mg daily for 12 weeks

Primary Outcome Measure Information:

Title

Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy

Description

This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy

Time Frame

24 weeks

Title

Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy

Description

Patients who attain serum PSA levels below 0.03microg/L

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide

Description

Adverse effects as defined by CTCAE criteria grade 3 and above

Time Frame

12 weeks

Title

The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy

Description

The level of complications defined by Clavien-Dindo classification

Time Frame

24 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lui Shiong Lee, MBBS,MRCS

Organizational Affiliation

Singapore General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Urology

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36000794

Citation

Yang X, Allen JC, Aslim EJ, Tay KJ, Yuen SPJ, Kanesvaran R, Chua MLK, Chong TW, Ho SSH, Lee LS. Patient-reported outcomes of a phase II neoadjuvant apalutamide (ARN-509) and radical prostatectomy in treatment of intermediate- to high-risk prostate cancer (NEAR) trial. Int J Urol. 2022 Nov;29(11):1322-1330. doi: 10.1111/iju.14994. Epub 2022 Aug 24.

Results Reference

derived

PubMed Identifier

35091711

Citation

Lee LS, Sim AYL, Ong CW, Yang X, Ng CCY, Liu W, Rajasegaran V, Lim AMS, Aslim EJ, Ngo NT, Khor LY, Kanesvaran R, Allen JCJ, Tay KJ, Yuen JSP, Chong TW, Ho SSH, Teh BT, Chua MLK. NEAR trial: A single-arm phase II trial of neoadjuvant apalutamide monotherapy and radical prostatectomy in intermediate- and high-risk prostate cancer. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):741-748. doi: 10.1038/s41391-022-00496-8. Epub 2022 Jan 28. Erratum In: Prostate Cancer Prostatic Dis. 2022 Mar 14;:

Results Reference

derived

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

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