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

Phase 2

Completed

• Conditions: hormone refractory prostate cancer; 10038594; 10036958

• Registration Number: NL-OMON35127
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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.

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression free survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Tolerability, safety, PSA and tumor response, survival, QoL.</p><br>