A randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY - RECARDO

• Conditions: Hormone refractory prostate cancer

• Registration Number: EUCTR2007-004335-39-NL
• Lead Sponsor: VU Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

1.18 years and above.
2.Histologically proven hormone refractory prostate adenocarcinoma.
3.PSA and/or clinical response on prior docetaxel-based chemotherapy with a progression free interval of over 3 months.
4.Last PSA value = 5 ng/ml within 2 weeks prior to registration (HYBRITECH equivalent)
5.Patients without surgical castration must continue on LHRH agonist therapy
6.ECOG performance status = 2
7.Gleason score 8-10
8.Adequate haematological, liver and renal function.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.More than 1 line of chemotherapy.
2.Prior platinum chemotherapy.
3.Radiotherapy within 2 weeks prior to treatment start.
4.Uncontrolled hypercalcemia.
5.Evidence of symptomatic brain and leptomeningeal metastatic disease.
6.Previous or concurrent malignancies at other sites (except basal squamous cell carcinoma of the skin).

Study & Design

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