Actively Recruiting
Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer
Led by National Taiwan University Hospital · Updated on 2022-04-07
38
Participants Needed
2
Research Sites
1013 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 20 to 75 years old
- Signed informed consent indicating understanding of the study and willingness to participate
- Histologically confirmed adenocarcinoma of the prostate
- High-risk locally advanced prostate cancer defined by at least one of: T3a-3b by DRE or MRI, Gleason score 8 or higher, PSA 20 ng/ml or higher
- Willing to undergo radical prostatectomy as primary treatment
- ECOG Performance Status 0 or 1
You will not qualify if you...
- Pathological diagnosis of small cell, ductal, or neuroendocrine carcinoma
- Previous or current hormone therapy, radiotherapy, or chemotherapy
- Evidence of metastasis (M1) on imaging
- Prior malignancy within 5 years before enrollment
- Severe or unstable angina, recent myocardial infarction, symptomatic heart failure, thromboembolic events, or significant heart arrhythmias within 6 months before first study drug dose
- HIV positive with uncontrolled infection, recent changes in antiretroviral therapy, interfering medications, low CD4 count (<350), or recent AIDS-defining infections
- Active or symptomatic viral hepatitis or chronic liver disease with complications
- History of seizures or conditions predisposing to seizures within 1 year before randomization
- Gastrointestinal conditions affecting drug absorption
AI-Screening
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Trial Site Locations
Total: 2 locations
1
National Taiwan University Hospital Yunlin Branch
Douliu City/Huwei Township, Yunlin County, Taiwan
Actively Recruiting
2
National Taiwan University Hospital
Tapiei, Taiwan
Actively Recruiting
Research Team
C
Chi-Shin Tseng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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