Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy given as a primary treatment to patients with early and rapid PSA rising after prostatectomy for high risk disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

1. Diagnosis of prostate adenocarcinoma on a radical prostatectomy.

2. Prior radical prostatectomy within less than 2 years from the time of first PSA rise.

3. Demonstration of biochemical recurrence based on a PSA detectable >0.03 less than 24 months after radical prostatectomy and confirmed on 2 additional tests.

4. PSA doubling time over three values must be <= 9 months for PSA >=0.4 and PSA <=10. If PSA is >10, there is no need for PSA doubling time.

5. Karnofsky performance status (KPS) >=70%

6. Adequate organ function as defined by hemogram with haemoglobin >8.0, platelet >100 000, white blood cell >3,500, creatinine clearance >=60 cc/min and normal liver function tests.

7. Neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that the total duration of therapy did not exceed 6 months.

8. Subjects must have signed an informed consent document stating that they understand the investigational or nature of the proposed treatment.

9. Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion Criteria:

1. Clinical significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.

2. Uncontrolled serious active infection.

3. Anticipated duration of life less than 2 years.

4. Less than 5-year history of successful treatment for other cancers or concurrent active non prostate cancer other than non melanoma dermatologic tumors and non-muscle invasive bladder tumors.

5. Peripheral neuropathy >=2 grade 2

6. Concurrent experimental treatment or involvement in other clinical trials involving drugs.

7. Other severe acute or chronic medical conditions including psychiatric diseases or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety.

8. Subjects who participated in another clinical study/received investigational product within 30 days of screening for this study.