Prostvac in Patients With Biochemically Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Prostvac in Patients With Biochemically Recurrent Prostate Cancer

Status Completed

Clinical Trial Summary

Background:

Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer.

Objective:

To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone.

Eligibility:

Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer

Design:

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Bone scan

Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission tomography (PET) scan: They lie in a machine that takes pictures of the body.

Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.

Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months.

During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months.

Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests.

Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.

Clinical Trial Description

BACKGROUND

• Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (biochemically recurrent prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer and to do so with limited toxicity.

• Prostvac (Prostvac; developed by the National Cancer Institute [NCI] and licensed to BN Immunotherapeutics, Mountain View, CA) is a novel candidate prostate cancer immunotherapy for the treatment of prostate cancer. It is a viral vector based therapeutic cancer vaccine that is administered via subcutaneous injections. In a randomized controlled Phase 2 trial, Prostvac therapy was associated with a prolongation of survival in men with metastatic castrate-resistant prostate cancer. A phase III trial recently completed accrual of patients in this same population.

• There is also rationale to use therapeutic cancer vaccines such as Prostvac in earlier stage prostate cancer patients to maximize the potential therapeutic effect of immune stimulating therapy.

• Analysis of previous trials using therapeutic cancer vaccines alone suggests that such therapies may alter tumor growth rate.

OBJECTIVE

Primary Objective:

-Determine if the therapeutic cancer vaccine prostvac can decrease tumor growth rate as measured by prostate-specific antigen (PSA) rise after 6 months compared to a group getting surveillance alone.

KEY ELIGIBILITY CRITERIA

• Histologically confirmed adenocarcinoma of the prostate

• Patients with negative computed tomography (CT) Scan and Tc-99m Bone Scan

• Patients with a PSA over 0.8 ng/ml for patients following radical prostatectomy or for patients following definitive radiation therapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir

• Patients with a PSA doubling time of 5-15 months

• No history of active autoimmune disease or history of organ compromising autoimmune disease

• Eastern Cooperative Oncology Group (ECOG) 0 -1

DESIGN

• Randomized study

• Accrual goal is 36 evaluable patients per arm; randomized 1:1 to:

• Arm A: Prostvac for 6 months with an additional optional year of maintenance for eligible patients OR

• Arm B: Surveillance for 6 months, then Prostvac for 6 months with an additional year of maintenance for eligible patients ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT02649439
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2015
• Completion date: October 1, 2022