Who is sponsoring NCT00108732?

NCT00108732 is sponsored by National Cancer Institute (NCI).

What condition does NCT00108732 study?

NCT00108732 studies Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer.

What drugs are being tested in NCT00108732?

Interventions: Bicalutamide, Goserelin Acetate, Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine, Recombinant Vaccinia-TRICOM Vaccine, Sargramostim.

What is the status of NCT00108732?

NCT00108732 is currently COMPLETED.

Last reviewed 2015-06-03 · How we verify

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

NCT00108732 Phase 2 COMPLETED Results posted

Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer. This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	COMPLETED
Enrolment	50
Start date	2006-02
Completion	2010-10

Conditions

Recurrent Prostate Carcinoma
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer

Interventions

Bicalutamide
Goserelin Acetate
Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine
Recombinant Vaccinia-TRICOM Vaccine
Sargramostim

Primary outcomes

Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation) — Assessed at 6 months
For patients who achieved a \> 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater. Changes in PSA below 5 ng/mL will not be considered assessable for progression. For patients whose PSA has not decreased by 50%, an increase in PSA value \> 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL.

Countries

United States