RTaxot: Docetaxel-based concurrent chemo-hormono-radiation in high and very high-risk prostate cancer patients: a phase II multicenter trial - RTaxot

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10061183; high and very high-risk prostate cancer patients

• Registration Number: EUCTR2010-019139-36-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-26
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Histologically proven adenocarcinoma of the prostate 2. Prostate cancer patients with two or more of the following prognostic factors: cT2b or T2c or Gleason Score (GS) = 7 or PSA between 10 and 20 ng/ml 3. Prostate cancer patients with High Risk of Recurrence according to NCCN definition :cT3a or GS = 8-10 or PSA > 20 ng/ml 4. Prostate cancer patients with Very High Risk of Recurrence according to NCCN definition(6- NCCN): cT3b-T4 or patients with multiple adverse factors included into the definition of High Risk
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.cN1 patients 2.Patients with history of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin. 3.Patients with history of previous radiotherapy to the abdomen or pelvis 4.Patients with history of previous chemotherapy (during preceding two years) 5.Uncontrolled diabetes 6.Inflammatory Bowel Diseases (Crohn`s disease, ulcerative colitis), acute diverticulitis, diverticulosis of the sigma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the activity (the 5year-biochemical control rate according to the Houston biochemical relapse definition);Secondary Objective: To determine the tolerability (the safety profile, determination of non dose limiting toxicity);Primary end point(s): the activity (the 5year-biochemical control rate according to the Houston biochemical relapse definition)