eoadjuvant chemotherapywith weekly docetaxel followed from concomitant docetaxel-RT in patients with high risk locally advancedprostate cancer - docrtpc
- Conditions
- high risk locally advancedprostate cancerMedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer
- Registration Number
- EUCTR2008-003525-16-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Histological diagnosis of prostate adenocarcinoma
Locally advanced disease with at least two of the following criteria:
-Gleason Score >6
-PSA : 10-40 ng/mL
->T2b N0M0
-Biopsy fragments positive for cancer ( > 50% della loro lunghezza) in both prostate lobes
No distant metastases
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
No peripheral neuropathy
No uncontrolled infection
No uncontrolled diabetes mellitus
No previous pelvic irradiation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Feasibility in terms of activity and tolerability of docetaxel weekly administered in neoadjuvant and rt-concomitant setting in high risk locally advanced<br>prostate cancer;Secondary Objective: progression free survival<br>time to prostate-specific antigen failure<br>local control<br>identification of genes as tumor response markers<br>quality of life;Primary end point(s): Early and late toxicity measured with the EORTC/RTOG scale<br>Biochemical, clinical and histological progression free survival
- Secondary Outcome Measures
Name Time Method