Phase III clinical trial comparing treatments of hormone-refractory prostate cancer (HRPC) with Docetaxel: continuous treatment vs. intermittent repetition of treatment after progression. - PRINCE

• Conditions: Treatment of hormone-refractory prostate cancer (HRPC); MedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer

• Registration Number: EUCTR2005-001602-76-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• adenocarcinoma of the prostate confirmed by histology or cytology
• metastasized adenocarcinoma of the prostate that is refractory to hormone
treatment, ie, that does no longer respond to hormone therapy and/or the current
treatment with estramustine
• documented progression under the last therapy (definite PSA-increase that is
confirmed by 2 subsequent measurements separated by at least 2 weeks, or
increase of measurable lesions by at least 25% that is confirmed by radiological
measurements)
• previous hormone therapy
• ECOG performance status <= 2 (Karnofsky index >= 60%)
• adequate hematological, cardial and hepatic function defined by the following
parameters:
- absolute neutrophil count >= 2 x 109/l
- thrombocytes >= 100 x 109/l
- hemoglobin >=10 g/dl (6.2 mmol/l)
- total serum bilirubin <= ULN
- AST (SGOT) and ALT (SGPT) <= 1.5 x ULN
- alkaline phosphatase <= 5 x ULN
• life expectancy >= 12 weeks
• written informed consent
• age >= 18 years

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

• previous therapy with isotopes
• previous chemotherapy (except estramustine)
• radiotherapy in the 4 weeks prior to enrollment
• previous radiotherapy if this concerned all lesions that are used for the evaluation
of tumor response
• previous radiotherapy if this concerned more than 25% of bone marrow
• previous or concomitant neoplasm (except curatively treated in situ carcinoma and
basal cell carcinomas of the skin as well as curatively treated neoplasms without
recurrence in the 5 years prior to enrollment
• previous or current cerebral metastases or leptomeningeal involvement
• current peripheral neuropathy >= grade 2 (CTCAE 3.0)
• renal inusufficiancy requiring dialysis
• chronic diarrhea (now or in medical history)
• other relevant concomitant diseases:
a) congestive heart failure or uncontrolled angina pectoris, previous myocardial
infarction within 6 months prior to enrollment, uncontrolled arterial
hypertension or arrhythmias
b) known significant neurological or psychiatric diseases including dementia and
epileptic seizures
c) active infections requiring intravenous administration of antibiotics
d) ulcerations, not stable diabetes mellitus or other contraindications with regard
to the administration of high doses of corticosteroids
e) untreated vena-cava-syndrome
f) known ascites or pericardial effusion
g) known symptomatic pleural effusion that requires tapping
• concomitant treatment with other anti-tumor therapies except LHRH-agonists in a
constant dose (for at least 4 weeks prior to enrollment) which should be continued
• participation in a clinical trial within 30 days prior to enrollment
• being anable to complie with therapy and investigations

Study & Design

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