Provenge + CT-011 + cyclophosphamide in treatment of mCRPC


The Georgia Health Sciences University in Augusta, GA, has initiated a new trial of sipuleucel-T (Provenge) in combination with cyclophosphamide and an investigational drug known as CT-011 for the treatment of chemotherapy-naive patients with progressive, metastatic, castrate-resistant prostate cancer (mCRPC).

Based on the information about the trial on the ClinicalTrials.gov web site, a total of 57 patients will be randomized to one of three arms of this trial:

  • Patients in Group A will be treated only with standard sipuleucel-T therapy in three cycles.
  • Patients in Group B will be treated with sipuleucel-T in three cycles + an intravenous infusion of CT-011 delivered over approximately 2 hours, 2 days after each infusion of sipuleucel-T.
  • Patients in Group C will be treated with sipuleucel-T in three cycles + intravenous cyclophosphamide (after the first cycle of sipuleucel T only) + an intravenous infusion of CT-011 delivered over approximately 2 hours, 2 days after each infusion of sipuleucel-T.

Presumably about 19 patients will be randomized to each group of patients in the trial.

According to a media release from the Georgia Health Sciences University, CT-011 is “a type of antibody that reverses immune suppression caused by cancer.” Data from animal studies have shown that combining sipuleucel-T with CT-011 and cyclophosphamide resulted in a significant increase in survival and complete tumor regression in more than 50 percent of mice. More information about CT-011 can be found on the web site of the developer of this investigational agent.

Patients who may be interested in learning more about this trial are advised to contact the referral office of the Georgia Health Sciences University (Tel: 1-888-658-0422) and to refer to this trial by it formal code number, which is NCT01420965.

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