This trial is active, not recruiting.

Conditions prostate cancer, hormone refractory
Treatment sunitinib (su011248)
Phase phase 2
Sponsor AHS Cancer Control Alberta
Collaborator Pfizer
Start date October 2007
End date November 2012
Trial size 30 participants
Trial identifier NCT00550810, SMART, TBCC-0707001


The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.

Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Progression Free Survival
time frame: 180 days without evidence of disease progression would be considered clinically worthy of further investigation

Secondary Outcomes

-PSA Response -Toxicity
time frame: The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise.

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histological or cytological diagnosis of adenocarcinoma of the prostate - Metastatic or locally recurrent disease not curable with standard therapy - ECOG performance status 0, 1 or 2 - Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment Exclusion Criteria: - Patients with a history of other invasive cancer, except adequately treated non - melanoma skin cancer. - Patients with known brain metastases. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248. - Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.

Additional Information

Official title A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.