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Cancer Vaccine

Sipuleucel-T + BAT for Prostate Cancer

Phase 2

Recruiting

Led By Joseph W Kim, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response

ii. Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression

Must not have

Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer

Prior prednisone >10mg (or its equivalent) within 2 weeks prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of registration until the date of death from any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to improve current cancer treatment for prostate cancer patients with a new therapy combining BAT & Sipuleucel-T.

Who is the study for?

Men with metastatic castration-resistant prostate cancer (mCRPC) who have not been treated with more than two androgen/AR signaling inhibitors, no prior chemotherapy for mCRPC within the last year, or recent systemic anti-cancer therapy. Participants must be in good health otherwise, with proper liver and kidney function, a low PSA level (<20ng/dL), and an ECOG Performance Status of 0 or 1.

What is being tested?

This phase II trial is testing the combination of Sipuleucel-T (a prostate cancer vaccine) with bipolar androgen therapy (BAT), using Testosterone Cypionate to see if it can boost immune response against prostate cancer cells in men whose disease has resisted standard hormonal treatments.

What are the potential side effects?

Potential side effects include typical immune-related reactions such as fever, chills, fatigue; hormone therapy effects like mood swings, weight gain; injection site pain from the vaccine; plus any general risks associated with testosterone treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PSA levels have risen twice, each time by at least 50% and are over 1.0 ng/mL.

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My bone scans show 2 or more new areas of concern since starting hormone therapy.

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My cancer has spread to other parts of my body, confirmed by scans.

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My prostate cancer is growing despite hormone therapy.

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My cancer has worsened or spread since starting hormone therapy.

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My last treatment didn’t stop my cancer from getting worse.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My testosterone levels are below 50ng/dL.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received Sipuleucel-T or high-dose testosterone for prostate cancer.

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I haven't taken more than 10mg of prednisone or similar medication in the last 2 weeks.

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I am taking more than 10mg of prednisone daily for an autoimmune disease.

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I haven't had a fever or needed IV antibiotics in the last week.

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I had palliative radiotherapy less than 2 weeks ago.

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I have HIV, Hepatitis B, Hepatitis C, or HTLV-1.

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I have used strong painkillers for cancer pain within the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of registration until the date of death from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of registration until the date of death from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of registration until the date of death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the immune response to PA2024 with BAT and Sipuleucel-T

Secondary study objectives

To assess safety and tolerability to BAT+ Sipuleucel-T

To determine APC number

To determine PSA50 response rate to BAT + Sipuleucel-T

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Testosterone Cypionate + Sipuleucel-TExperimental Treatment2 Interventions

Participants will start with testosterone injection every 4 weeks. The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule. The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sipuleucel-T

2017

Completed Phase 3

~890

Testosterone Cypionate

2011

Completed Phase 2

~150