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

NCT ID: NCT04894188

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2041-07-01

Brief Summary

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

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

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).

Goserelin 3.6 MG

Intervention Type: DRUG

Gosereline 3.6mg sc injection at week 1, week 5, and week 9

radical prostatectomy

Intervention Type: PROCEDURE

Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection

Neoadjuvant ADT

Gosereline 3.6mg sc injection at week 1, week 5, and week 9

Group Type: ACTIVE_COMPARATOR

Goserelin 3.6 MG

Intervention Type: DRUG

Gosereline 3.6mg sc injection at week 1, week 5, and week 9

radical prostatectomy

Intervention Type: PROCEDURE

Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection

Interventions

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).

Intervention Type: RADIATION

Goserelin 3.6 MG

Gosereline 3.6mg sc injection at week 1, week 5, and week 9

Intervention Type: DRUG

radical prostatectomy

Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection

Intervention Type: PROCEDURE

Other Intervention Names

ZOLADEX

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao-Yuan Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital Yunlin Branch

Douliu City/Huwei Township, Yunlin County, Taiwan

Site Status: RECRUITING

National Taiwan University Hospital

Tapiei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chi-Shin Tseng, MD

Role: CONTACT

clifford1987tcs@gmail.com

+886223123456

Facility Contacts

Shi-Wei Huang, PhD

Role: primary

Will6438.huang@gmail.com

Chi-Shin Tseng, MD

Role: primary

clifford1987tcs@gmail.com

Other Identifiers

202101088RINA

Identifier Type: -

Identifier Source: org_study_id