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Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT04894188
Study type Interventional
Source National Taiwan University Hospital
Contact Chi-Shin Tseng, MD
Phone +886933381228
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date July 1, 2021
Completion date July 1, 2041

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