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Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

NCT05406999•The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

Detailed Description

The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.

Eligibility

Age

18 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
•2. All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1).
•3. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
•4. Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
•5. Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must bewilling to obey the prohibitions and restrictions specified in the research protocol.
•6. Fertile patients must be willing to use highly effective contraception during the study period and within 120 days of the last dose of treatment.

Exclusion Criteria

•6. Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
•7. Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
•8. Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.

Locations (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China

Key Dates

Start Date

February 1, 2020

Primary Completion Date

December 31, 2026

Completion Date

June 30, 2030

Last Updated

August 16, 2022

Enrollment

900

ESTIMATED participants

Conditions

Neoadjuvant TherapyHigh Risk Prostate CancerLocally Advanced Prostate CancerIntense Endocrine Therapy

Interventions

ADT

DRUG

Abiraterone Acetate

DRUG

Prednisolone tablets

DRUG

Enzalutamide

DRUG

Apalutamide

DRUG

Darotamide

DRUG

Rezvilutamide

DRUG

PARP inhibitor

DRUG

Robot-assisted radical prostatectomy

PROCEDURE

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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: August 16, 2022Data 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

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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