Hormonal therapy is the standard treatment for prostate cancer which has spread to other areas of the body. Despite the high initial response rates to hormonal therapy, the vast majority of men will develop cancer which is no longer responsive to hormone deprivation. The average time for hormonal therapy to be effective is about 18 months. Chemotherapy combinations which can treat the disease when it no longer responds to hormonal therapy have been developed, but these treatments are not curative. One of these combinations is estramustine, etoposide and paclitaxel. In men with far advanced disease, 60% will have a decrease in their PSA or shrinkage of tumors after treatment with this chemotherapy. Despite this, these men have all developed further disease progression requiring additional treatment. One possible way to make chemotherapy more effective is to give it when the number of tumor cells is smallest, and the number of cells to be killed is at a low level. One situation in which this is true is when a man has responded to hormonal therapy any tumors are at their smallest size. This study will test whether the addition of chemotherapy at that time will prolong the time until the cancer becomes unresponsive to hormonal therapy.

Condition	Intervention	Phase
Prostate Cancer	Drug: Oral Estramustine, Oral Etoposide, Intravenous Paclitaxel	Phase II

Further Study Details: 

Primary Outcomes: Estimate the time to treatment failure in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.; Determine the overall survival in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.; To evaluate the type, frequency and severity of toxicity in this patient population.
Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

All patients must have a histologic diagnosis of adenocarcinoma of the prostate with evidence of metastases on bone or CT scan. Patients with regional metastases to pelvic lymph nodes (D1 disease) as their only site of metastases will be excluded from this study.

Patients on androgen suppression therapy at the time of registration must have received less than seven months of therapy (excluding any neoadjuvant hormonal therapy) and must have a decreasing or stable PSA level.

Patients may not be undergoing concurrent chemotherapy, biologic therapy, or radiation therapy. Prior to radiation therapy must have completed more than 4 weeks prior to registration.

Patients may not have received prior cytotoxic chemotherapy.

Patients may not have evidence of brain metastases or untreated spinal cord compression.

Michigan
      The University of Michigan Comprehensive Cancer, Ann Arbor,  Michigan,  United States

Study chairs or principal investigators

David C. Smith, MD,  Principal Investigator,  The University of Michigan Comprehensive Cancer Center   

Study ID Numbers:  UMCC 9815
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00151060
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13