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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03297385
Other study ID # N14DAR
Secondary ID
Status Completed
Phase Phase 2
First received April 13, 2017
Last updated September 28, 2017
Start date August 28, 2014
Est. completion date April 1, 2017

Study information

Verified date August 2017
Source The Netherlands Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment.

Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.

Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.


Description:

Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment.

Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.

Study design: A phase II prospective single-arm analysis. With a power of 80% to detect an expected reduction in positive surgical margin rate from 34% to 17% the investigators will have to included 55 men. For the AR/DNA interaction patients will serve as there own control since biopsies will be taken before and after enzalutamide treatment.

Study population: Patients over 18 years of age with localized prostate cancer that are planned for prostatectomy.

Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.

Main study parameters/endpoints: 1. The effects of neoadjuvant androgen ablation on tumor downstaging. 2. The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden and risks: Patients will be submitted to an additional set of 4 tumor targeted biopsies under local anesthesia and antibiotic prophylaxis. This comprises a 5 minute intervention with an elevated (2%) risk of postbiopsy urinary tract infection. Additionally oral enzalutamide treatment for a period of 3 months will result in temporary signs of androgen ablation such as: hot flushes (20%), headache (12%), diarrhea (1%), and seizures (0.9%). Benefits: neoadjuvant enzalutamide treatment has been shown to result in tumor and prostate downsizing. Earlier neoadjuvant androgen ablation studies with other agents have shown a reduced positive surgical margin rate and reduced intraoperative blood loss


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 1, 2017
Est. primary completion date April 1, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Men over 18 years of age.

2. clinically non-metastasized prostate cancer, tumor that can be imaged (TRUS or MRI) in order to allow for accurate preoperative biopsies.

3. Gleason score 7-10

4. written informed consent

5. WHO performance 0-1

Exclusion Criteria:

1. A history of seizures.

2. Clinically nodal metastases.

3. Prostatitis or urinary tract infection.

4. Androgen ablative therapy within 6 weeks of inclusion (including 5 alpha-reductase inhibitors).

5. Tumor of the prostate that can not be visualized by TRUS or MRI.

Study Design


Intervention

Drug:
Enzalutamide
Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Netherlands Cancer Institute Astellas Pharma Inc

Outcome

Type Measure Description Time frame Safety issue
Primary Effects of enzalutamide on tumor downstaging To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression. From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Primary Genetic and transcriptional changes caused by enzalutamide The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide. From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Secondary Clinical down-staging of enzalutamide pretreatment To assess the effects of 3 months enzalutamide pretreatment on clinical down-staging From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Secondary AR-chromatin binding alterations and Ki-67 expression Study the correlation between AR-chromatin binding alterations and Ki-67 expression. From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Secondary AR-dependant genes such as PSA, human kallikrein and PSMA Compare the AR-chromatin binding with expression alterations of known AR-dependent genes such as PSA, human kallikrein and PSMA. From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Secondary Gleason grading Compare AR-chromatin binding patterns with Gleason grading. From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Secondary Find associated genes in prostate tissue, using tissue microarray (TMA). Find associated genes on TMA derived from prostatectomy specimens. From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
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