RecruitingNot ApplicableNCT04894188

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

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


Sponsor

National Taiwan University Hospital

Enrollment

38 participants

Start Date

Jan 27, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment sequence for men with high-risk locally advanced prostate cancer: hormone therapy and radiation to the prostate first, followed by surgical removal of the prostate (radical prostatectomy). Most patients receive hormone therapy or radiation OR surgery, not both in combination, so this study looks at whether the combined approach improves outcomes. **You may be eligible if...** - You are between 20 and 75 years old - You have biopsy-confirmed prostate cancer classified as high-risk (stage T3a or higher on MRI, Gleason score 8 or higher, or PSA of 20 ng/mL or higher) - You are willing and able to undergo a prostatectomy after hormone and radiation therapy - Your performance status is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have a rare form of prostate cancer (small cell, ductal, or neuroendocrine) - You have already received hormone therapy, radiation, or chemotherapy - Your cancer has spread to other parts of the body (metastatic) - You have had another cancer in the past 5 years - You have had recent serious heart events (heart attack, stroke, severe angina) in the past 6 months - You have uncontrolled HIV, active hepatitis, or a history of seizures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONradiation 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).

DRUGGoserelin 3.6 MG

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

PROCEDUREradical prostatectomy

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


Locations(2)

National Taiwan University Hospital Yunlin Branch

Douliu City/Huwei Township, Yunlin County, Taiwan

National Taiwan University Hospital

Tapiei, Taiwan

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NCT04894188


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