The PORTER Trial

Why This Trial

Prostate cancer remains the second leading cause of cancer death among men in the United States. While the 5-year survival for early stage prostate cancer is very high, almost one-third of early stage cases will come back and progress into metastatic disease. For those patients, the 5-year survival rate drops to about 30%.

Standard treatment of prostate cancer lowers the level of hormones that drive cancer growth. The treatment is usually effective in the short term; however, metastatic prostate cancer will eventually continue to grow and spread despite hormone-based therapy, progressing into metastatic castration-resistant prostate cancer (mCRPC). This trial aims to study how to overcome this advanced disease.

About the Study

This study seeks to test a variety of treatment combinations, developed by prostate cancer experts across the field, to fight this difficult-to-treat form of advanced prostate cancer.

We are employing an exploratory “platform” or “master protocol” design. This relatively new type of trial framework provides the flexibility to evolve the study to include new treatment combinations as the trial progresses to advance scientific discovery more quickly and efficiently.

With the platform design, researchers can build on emerging data and test promising new therapies in the same study rather than starting a new study. It can cut down on administrative steps needed to start a study, adding efficiency so that new therapies can be developed to help patients faster.

Who’s Eligible

Men with prostate cancer that has spread and is resistant to standard of care, including hormonal therapy.

Treatments Tested

Multiple groups of patients will be treated with different combinations of therapies. The groups of patients and number of combinations will grow over time. Currently, the planned treatment combinations include:

• Cohort A: Peg-IL-2 + Anti-PD-1
• Cohort B: Stereotactic body radiation therapy (SBRT) + FLT3 ligand + PAMP adjuvant + Anti-PD-1
• Cohort C: FLT3 ligand + DNA-based vaccine with PSA, PSMA and IL-12 plasmids + Electroporation + Anti-PD-1

Where We’re At Now

The trial began enrolling the first patients in June 2019. By the end of 2019, we activated three cohorts and began testing three multi-drug combinations on parallel tracks.

Cohort A completed enrollment in December 2019, and the team is now focused on delivering clinical and translational analyses. Cohort B has since completed enrollment. Cohort C remains open for enrollment.

Several more drug combinations are under consideration.