TEM Prostate

Official Title

A Phase II Study of Maintenance Therapy With Temsirolimus in Androgen-Independent Prostate Cancer After First Line Chemotherapy With Docetaxel

Summary:

This is a clinical trial (a type of research study). You are being asked to consider taking part in this study because you have cancer of the prostate gland that no longer responds to hormonal treatment, and are receiving treatment with docetaxel and prednisone. The usual care is to continue the chemotherapy (docetaxel) until your cancer no longer responds to the treatment, or to have a break with re-treatment with chemotherapy when the cancer progresses. Eventually, prostate cancer no longer responds to docetaxel chemotherapy.

This research is being done to find out if temsirolimus given to patients after docetaxel and prednisone therapy can delay the progression of prostate cancer. 

Trial Description

Primary Objective

• To determine the effect of temsirolimus maintenance therapy on time to treatment failure (TTF) in patients who have responded to a course of first-line chemotherapy for AIPC with docetaxel.

Secondary Objectives

• Safety assessment using NCI-CTCAEv3.0 (NCI Common Terminology Criteria for Adverse Events, Version 3.0)
• Quality of life assessment using FACT-P (Functional Assessment of Cancer Therapy – Prostate) and PPI (Present Pain Intensity Index)
• Changes in PSA doubling time
• Time to PSA progression
• Objective tumour response rate according to RECIST criteria
• Overall survival
• Correlation of serum/plasma surrogate markers of mTOR inhibition, (anti)angiogenic activity, intratumoral hypoxia/pH and bone metabolism markers with TTF and other outcome measures.

Eligible patients will receive temsirolimus at a dose of 25 mg IV every week until disease progression or unacceptable toxicity.  One cycle consists of 4 weeks of therapy. At the time of treatment failure, further therapy (not with temsirolimus) is at the discretion of the treating physician.

Reviewed by OCREB