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A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)

NCT02799745•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.

Detailed Description

This was a multicenter, randomized, open label exploratory study, conducted in the US and Canada, evaluating the efficacy and safety of enzalutamide for extension of time to prostate cancer progression (pathological or therapeutic) in patients with clinically localized, histologically proven prostate cancer that is categorized as low risk or intermediate risk and who were under AS.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically proven adenocarcinoma of the prostate diagnosed (with ≥10 core biopsy) within 6 months of screening. The biopsy that was used for this diagnosis must be submitted for central pathology review.
•Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA\<10, N0, M0 (or presumed N0, M0 if CT/bone scan not done due to low risk of metastases), GS ≤ 6, ECOG status ≤2 and estimated life expectancy \>5 years OR intermediate risk is defined as T2b-T2c, PSA\<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ≤7 (3+4 pattern only), ECOG status ≤ 2 and estimated life expectancy \> 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA \<10 ng/mL, fewer than 3 prostate biopsy cores positive,
•≤50% cancer in any core, PSA density \<0.15 ng/mL/g) is not included.
•Ability to swallow study drugs and to comply with study requirements throughout the study
•Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
•Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following:
•1. Condom (barrier method of contraception) AND
•2. One of the following is required:
•i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.
•Must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.

Exclusion Criteria

•Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
•Very low risk category (T1c, GS ≤6, PSA \<10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density \<0.15 ng/mL/g)
•Prior transurethral resection of the prostate or prior transurethral microwave thermotherapy of the prostate
•Use of oral glucocorticoids within 1 month of screening
•Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of \>3 months
•Presence of metastatic disease
•History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening
•Absolute neutrophil count \< 1,500/μL, platelet count \< 100,000/μL, or hemoglobin \< 6.2 mmol/L (10 g/dL) at screening
•Total bilirubin \>1.5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 X ULN at screening
•Creatinine \> 177 μmol/L (\> 2 mg/dL) at screening
+12 more criteria

Locations (54)

Site US10034

Birmingham, Alabama, United States

Site US10024

Homewood, Alabama, United States

Site US10007

Tucson, Arizona, United States

Site US10055

Tucson, Arizona, United States

Site US10004

Los Angeles, California, United States

Site US10026

Sacramento, California, United States

Site US10010

San Diego, California, United States

Site US10051

Aurora, Colorado, United States

Site US10029

Denver, Colorado, United States

Site US10054

Denver, Colorado, United States

Key Dates

Start Date

June 9, 2016

Primary Completion Date

August 28, 2020

Completion Date

August 28, 2020

Last Updated

December 6, 2024

Enrollment

227

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Enzalutamide

DRUG

Active Surveillance

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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