Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer

April 5, 2022 updated by: National Taiwan University Hospital

Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Locally Advanced Prostate Cancer and Biomarker Research

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy can fight prostate cancer by androgen deprivation. It is not yet known if neoadjuvant radiation therapy is a more effective therapy for high-risk prostate cancer.

PURPOSE: Two-stage randomized trial to compare the effectiveness and safety of neoadjuvant radiotherapy and hormone therapy followed by radical prostatectomy in men with high-risk locally advanced prostate cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Success rate of salvage radiation therapy (SRT) measured as pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate.

SECONDARY OBJECTIVES:

I. PSA decline rate after neoadjuvant treatment, rate of undetectable PSA after RP, rate of positive surgical margin, and rate of pathologic down-staging (≤ ypT2N0) II. Biochemical recurrence-free survival rate (from date of randomization). III. Metastasis free survival. IV. Prostate Cancer Death. V. Overall Survival

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive neoadjuvant hormone and radiation therapy, and then radical prostatectomy

ARM II: Participants receive neoadjuvant hormone therapy, and then radical prostatectomy.

After intervention, participants are followed up periodically for up to 20 years.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Tapiei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Chao-Yuan Huang, MD, PhD
    • Yunlin County
      • Douliu City/Huwei Township, Yunlin County, Taiwan
        • Recruiting
        • National Taiwan University Hospital Yunlin Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men with age from 20 to 75 years old
  • Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Histologically confirmed adenocarcinoma of the prostate

  • High-risk locally advanced disease defined by ≥1 of the following 3 criteria:

    • T3a-3b by DRE or MRI
    • Gleason score ≥ 8 (= Grade group 4)
    • PSA ≥20 ng/ml
  • Willing to undergo prostatectomy as primary treatment
  • ECOG Performance status 0 or 1

Exclusion Criteria:

  • Pathological finding of small cell, ductal or neuroendocrine carcinoma
  • Current or prior hormone therapy, radiotherapy, or chemotherapy
  • Evidence of metastasis (M1) on images
  • Other prior malignancy ≤5 years prior to enrollment
  • Any of the following within 6 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary

  • Human immunodeficiency virus-positive subjects with 1 or more of the following:

    1. Not receiving highly active antiretroviral therapy
    2. Had a change in antiretroviral therapy within 6 months of the start of screening
    3. Receiving antiretroviral therapy that may interfere with study drug (consult sponsor for review of medication prior to enrollment)
    4. CD4 count <350 at screening
    5. AIDS-defining opportunistic infection within 6 months of start of screening
  • Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
  • History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  • Gastrointestinal conditions affecting absorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant RT and ADT

Intensity modulated radiation therapy (IMRT), with 50 Gy in 25 daily fractions (2 Gy/fraction, 5 fractions weekly) for 5 weeks (week 1 - week 5).

Gosereline 3.6mg sc injection at week 1, week 5, and week 9
Radiation: radiation therapy
Intensity modulated radiation therapy (IMRT), with 50 Gy in 25 daily fractions (2 Gy/fraction, 5 fractions weekly) for 5 weeks (week 1 - week 5).
Drug: Goserelin 3.6 MG
Gosereline 3.6mg sc injection at week 1, week 5, and week 9
Other Names:
  • ZOLADEX
Procedure: radical prostatectomy
Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection
Active Comparator: Neoadjuvant ADT
Gosereline 3.6mg sc injection at week 1, week 5, and week 9
Drug: Goserelin 3.6 MG
Gosereline 3.6mg sc injection at week 1, week 5, and week 9
Other Names:
  • ZOLADEX
Procedure: radical prostatectomy
Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic outcome
Time Frame: From date of randomization to the date of radical prostatectomy, up to 100 weeks
pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate
From date of randomization to the date of radical prostatectomy, up to 100 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA decline percentage
Time Frame: From date of randomization to 10 years
PSA decline is defined as nadir PSA value/baseline PSA value × 100
From date of randomization to 10 years
PSA complete response rate
Time Frame: From date of randomization to 10 years
Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml.
From date of randomization to 10 years
PSA Recurrence
Time Frame: From date of randomization to 10 years
Biochemical recurrence is defined as a rise in PSA to 0.2 ng/mL and a confirmatory value of 0.2 ng/mL or greater following radical prostatectomy
From date of randomization to 10 years
Distant Failure
Time Frame: From date of randomization to 10 years
Distant failure rate is estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure.
From date of randomization to 10 years
Prostate Cancer Death
Time Frame: From date of randomization to 10 years
Prostate cancer death rate us estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of trial.
From date of randomization to 10 years
Overall Survival
Time Frame: From date of randomization to 10 years
Overall survival is estimated by the Kaplan-Meier method, with failure defined as death by any cause.
From date of randomization to 10 years
Progression-free Survival
Time Frame: From date of randomization to 10 years
Progress-free survival is estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause.
From date of randomization to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chao-Yuan Huang, MD, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2041

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 16, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101088RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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