Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer
Launched by UNIVERSITY OF ROME TOR VERGATA · Mar 17, 2014
Trial Information
Current as of June 07, 2025
Suspended
Keywords
ClinConnect Summary
Eligible patients had clinically localized (clinical TNM classification T1 or T2), biopsy-proven adenocarcinoma of the prostate and were randomly treated with RRP or EBRT. Exclusion criteria included prior treatment for prostate cancer, the presence of metastatic disease on imaging studies, the receipt of neoadjuvant androgen ablation before registration, and an inability to read or understand Italian language. The institutional review boards of every participating centre approved the study design. Every patient enrolled signed an informed-consent form approved by the institutional review b...
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Age 75 years or younger
- • Diagnosis of prostate cancer, as verified by cytologic or histologic examination the tumor is well differentiated to moderately well differentiated
- • Untreated, clinically localized prostate cancer, with a tumor stage of T1, or T2
- • Prostate specific antigen (PSA) level of ≤10 ng/ml
- • Bone scan with no abnormalities
- • Health status that would permit radical prostatectomy
- • Life expectancy of more than 10 years.
- Exclusion Criteria:
- • PSA \>10 ng/ml
- • Bone scan consistent with metastatic disease
- • Other evidence that cancer of the prostate is not clinically localized
- • Life expectancy less than 10 years
- • Serum creatinine greater than 3 mg/dl
- • Myocardial infarction within last 6 months
- • Unstable angina Class III or IV
- • Severe pulmonary disease
- • Liver failure
- • Severe dementia
- • Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years.
About University Of Rome Tor Vergata
The University of Rome Tor Vergata is a prestigious academic institution recognized for its commitment to advancing medical research and education. As a clinical trial sponsor, it leverages its extensive resources and expertise in various fields of health sciences to foster innovative research initiatives. The university collaborates with healthcare professionals, researchers, and industry partners to conduct rigorous clinical trials aimed at improving patient care and outcomes. With a focus on ethical standards and scientific integrity, the University of Rome Tor Vergata is dedicated to contributing to the global body of medical knowledge and translating research findings into practical applications for the benefit of society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Savino M. Di Stasi, MD, PhD
Study Chair
Tor Vergata University of Rome
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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