Actively Recruiting

Phase 2
Age: 18Years - 80Years
MALE
NCT05406999

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

Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2022-08-16

900

Participants Needed

1

Research Sites

543 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate cancer and eligibility for radical prostatectomy
  • Tumor staging showing primary tumor clinical stage T3 or higher by MRI or PSMA PET/CT
  • Gleason score of primary tumor 8 or higher
  • Prostate specific antigen (PSA) level of 20 ng/ml or higher
  • Imaging showing regional lymph node metastases (N1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate blood, liver, kidney, and heart function
  • Voluntary participation with signed informed consent
  • Fertile patients agree to use effective contraception during the study and for 120 days after last treatment
Not Eligible

You will not qualify if you...

  • Presence of neuroendocrine, small cell, or sarcoma-like prostate cancer features
  • Low or intermediate risk localized prostate cancer with all the following: tumor stage below T3, Gleason score below 8, and PSA below 20 ng/ml
  • Evidence of distant lymph node, bone, or visceral metastases (any M1 stage)
  • Previous treatment with androgen deprivation therapy, focal therapy, radiotherapy, or chemotherapy for prostate cancer
  • Severe or uncontrolled infections
  • New York Heart Association Class III or IV heart failure
  • Recent thromboembolic events, unstable angina, or myocardial infarction within 6 months
  • Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection
  • Other cancers within past 5 years except cured basal or squamous cell skin cancer
  • Mental illness, disability, or inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

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

Nanjing, Jiangsu, China, 210000

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

8

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here