Docetaxel met carboplatine versus docetaxel, een gerandomiseerde fase 2 studie bij patiënten met hormoonongevoelig prostaatkanker na eerdere respons op docetaxel-bevattende chemotherapie: RECARDO STUDIE.

1. Histologically proven prostate adenocarcinoma;

2. Hormone refractory prostate cancer;

3. Patients must have had PSA and/or clinical response and progression free for >3 months on first line chemotherapy with docetaxel for HRPC;

4. Patients must have progressed on prior chemotherapy with docetaxel; progression at study entry is defined as (confirmed) PSA progression and/or objective tumor progression whichever comes first (see 6.2.3);

5. Last PSA value ≥ 5 ng/ml within 2 weeks prior to registration (HYBRITECH equivalent);

6. Patients without surgical castration must continue on LHRH agonist therapy;

7. Age ≥ 18 years;

8. ECOG performance status ≤2;

9. Gleason score ≥ 7;

10. Adequate haematological functions as assessed by neutrophils >1,5x109/, platelets >100x109/L;

11. Adequate liver function as assessed by bilirubin <1,5 times the upper limit of the normal range and transaminases <5 times the upper limit of normal range in case of liver metastases and <2,5 times the upper limit of the normal range in absence of liver metastases;

12. Adequate renal function as assessed by serum creatinine <150 µmol/l (<1,7 mg/dl);

13. Psychological, familial and geographical conditions must permit adequate medical follow up and compliance with the study protocol;

14. Written informed consent according to ICH-GCP.

1. More than 1 line of chemotherapy;

2. No prior platinum allowed;

3. Radiotherapy within 2 weeks prior to treatment start;

4. Concurrent treatment with other experimental drugs;

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);

7. Uncontrolled systemic disease or infection;

8. Severe concomitant disease for which chemotherapy is contra-indicated.