Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Stopped early · Phase 2

Conditions studied: Hormone-Resistant Prostate Cancer, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

In brief

This randomized phase II trial studies how well docetaxel and prednisone with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from an antigen may help the body build an effective immune response to kill tumor cells. It is not yet known whether docetaxel and prednisone are more effective with or without vaccine therapy in treating prostate cancer.

Key facts

Study ID

NCT01145508

Run by

National Cancer Institute (NCI)

People needed

10

Starts

2010-08-01

Expected to finish

2015-10-01

Last updated by the study team

2017-09-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
• Patient must have metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (computed tomography [CT] of abdomen/pelvis, bone scintigraphy)
• Patient must have castrate-resistant disease, defined as follows:
• Patient must have received standard of care androgen deprivation treatment (ADT) before trial entry (surgical castration versus gonadotropin-releasing hormone [GnRH] analogue or antagonist treatment); subjects receiving GnRH analogue or antagonist must continue this treatment throughout the time on this study
• Patient must have been treated previously with a nonsteroidal antiandrogen, with evidence of subsequent disease progression; subjects must be off use of anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to randomization; subjects who demonstrate an anti-androgen withdrawal response, defined as a >= 25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen are not eligible until the PSA rises above the nadir observed after antiandrogen withdrawal
• Patient must have castration levels of testosterone (< 50 ng/dL) within 4 weeks prior to randomization
• Patient must have progressive disease while receiving ADT as defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria:
• PSA: at least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, and each value >= 2.0 ng/mL
• Measurable disease: >= 50% increase in the sum of the cross products of all measurable lesions or the development of new measurable lesions by RECIST criteria version 1.1; the greatest diameter of a target lesion must be at least 1.0 cm by CT scan (1.5 cm in shortest axis for lymph nodes)
• Non-measurable (bone) disease: the appearance of two or more new areas of uptake on bone scan consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or magnetic resonance imaging [MRI])
• Patient must not have poor prognosis features suggested by the following required information:
• Presence of visceral (non-lymph node, non-bone) metastases
• Poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status [PS] of 2 or greater)
• Alkaline phosphatase (IU/L) > 2 x institutional upper limit of normal
• Lactate dehydrogenase (LDH) (U/L) > 2 x institutional upper limit of normal
• Patient must have an ECOG performance status of 0 or 1
• White blood cell (WBC) count >= 2000/mm\^3
• Absolute neutrophil count (ANC) >= 1500/mm\^3
• Platelet count >= 100,000/mm\^3
• Creatinine =< 2.0 mg/dL
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 1.5 x institutional upper limit of normal (ULN)
• Total bilirubin < institutional upper limit of normal (ULN)
• Patient must have completed any prior treatments (apart from androgen deprivation as previously described) >= 4 weeks prior to randomization and have recovered (to < grade 2) from any acute toxicities attributed to this prior treatment
• Patient must agree to use an accepted and effective method of contraception prior to study entry and for the duration of study participation (or at least 4 months after the last vaccination in subjects receiving vaccine series); if patient impregnates a woman while participating in this study, he should inform his treating physician immediately
• Patient must not be receiving any other investigational agents or be receiving concurrent anticancer therapy other than ADT

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Hematology and Oncology Associates — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Hematology Oncology Associates of Illinois-Highland Park — Highland Park, Illinois, United States
• Presence Saint Mary's Hospital — Kankakee, Illinois, United States
• NorthShore Hematology Oncology-Libertyville — Libertyville, Illinois, United States
• Illinois Cancer Specialists-Niles — Niles, Illinois, United States
• Hematology Oncology Associates of Illinois - Skokie — Skokie, Illinois, United States
• Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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