Proton SBRT for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byShaakir Hasan, DO

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The New York Proton Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. The primary aim is to assess GU/GI toxicity of proton SBRT and compare this to historic outcomes associated with photon-based prostate SBRT. The primary endpoint is 2-year grade 3+ GU/GI toxicity free rate by CTCAE v5.0, which is expected to be ≥95%. Toxicity will be evaluated by the treating radiation oncologist at least once during SBRT, then following SBRT at 1, 3, 6, 12, 18, and 24 months. The treatment will be considered safe if grade 3 or higher GU/GI toxicity free rate at 2 years is \>85% (95% rate expected with a 10% non-inferiority margin). The accrual goal is 61 patients over 3 years. To ensure that unexpected significant toxicity is identified, all grade 3 or higher toxicities will be reported to the study PI and the trial will stop accruing if at any point 4 or more patients experience a grade 3 or higher toxicity after completing SBRT. This is felt to be conservative given the vast experience with photon SBRT at this dose with an expected G3+ toxicity of \~5%. Secondary objectives are to examine patient-reported urinary, gastrointestinal, sexual, and financial outcomes using IPSS, EPIC-26, and COST questionnaires at the same follow-up timepoints as above. Baseline measures of these domains will be obtained prior to treatment as well. Clinical outcomes will also be evaluated with PSA measured at each follow-up, as well as prostate MRI and biopsies at 2 years. Patients will be followed for at least 2 years to determine rates of PSA relapse, salvage treatment, development of metastases, death from prostate cancer, and overall survival. A dosimetric comparison will be performed where each patient will be planned for proton and photon SBRT to determine possible advantages of proton SBRT.

Research Team

Daniel Gorovets, MD

Principal Investigator

The New York Proton Center

Shaakir Hasan, DO

Principal Investigator

The New York Proton Center

Eligibility Criteria

Men over 18 with low or intermediate-risk prostate cancer, a Gleason score ≤7, PSA ≤20 ng/ml, and no prior major prostate surgery. They must have a life expectancy of more than 2 years and be able to follow up for at least that time. Participants need an IPSS score ≤20, KPS ≥80%, and agree to specific procedures like fiducial marker placement.

Inclusion Criteria

I am a man aged 18 or older.

My prostate is smaller than 100 cc, confirmed by MRI or CT scan.

IPSS ≤ 20

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Exclusion Criteria

I have had chronic prostatitis or a narrowed urethra in the past.

Your doctor estimates that you have less than 2 years to live.

I don't have active cancer, except for non-serious skin cancers, and my doctor thinks I'm unlikely to relapse soon.

See 2 more

Treatment Details

Interventions

Pencil Beam Scanning Proton SBRT (Proton Beam Therapy)

Trial OverviewThe trial is testing pencil beam scanning proton SBRT as a treatment for prostate cancer. It involves delivering radiation in five sessions every other day. The main goal is to see if this method causes less severe urinary or gastrointestinal side effects compared to traditional treatments after two years.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapyExperimental Treatment1 Intervention