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Search / Trial NCT02091661

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

Clinically Localized Prostate Cancer Radical Retropubic Prostatectomy External Beam Radiotherapy Efficacy Quality Of Life Adverse Events

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.

Locations

Patients applied

0 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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