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
• 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