Clinical trial NCT02091661: Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer
Official title: Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Clinically localized prostate cancer
Radical retropubic prostatectomy
External beam radiotherapy
Efficacy
Quality of life
adverse events
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 500
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.

Detailed description: 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 boards. Clinical information collected from the medical record included pre-treatment serum prostate-specific antigen (PSA) level, clinical T classification, and biopsy Gleason score. Follow-up assessments were completed before treatment and every 3 months after treatment. Subjects who sought primary treatment elsewhere or did not return follow-up questionnaires beyond the initial assessment were excluded from this analysis.

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.

Primary outcomes:
measure: Biochemical disease-free survival
timeFrame: up to 12 months
Secondary outcomes:
measure: •Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).
timeFrame: 1, 3, 6, 12 and 24 months after treatment.
measure: •Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).
timeFrame: 1, 3, 6, 12 and 24 months after treatment.
measure: •Urinary symptoms measured by the International Prostate Symptom Score (IPSS).
timeFrame: 1, 3, 6, 12 and 24 months after treatment.
measure: •Sexual symptoms measured by the International Index of Erectile Function (IIES).
timeFrame: 1, 3, 6, 12 and 24 months after treatment.
measure: Overall survival.
timeFrame: 5, 7 and 10 years after treatment and every 5 years thereafter.
measure: Prostate cancer-specific survival
timeFrame: 3, 5, and 10 years after treatment and then every 5 years thereafter
Other outcomes:
Locations:
Study officials:
affiliation: Tor Vergata University of Rome
name: Savino M. Di Stasi, MD, PhD
role: STUDY_CHAIR
References: