Rectal Spacers Use in Prostate Cancer Radiation Therapy

Recruiting N/A Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Male
Study type
Interventional
Purpose
Supportive Care
Participants needed
50 (estimated)
Sponsor
Princeton ProCure management, LLC. · Other
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About This Trial

This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.

Trial Locations
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Eligibility Criteria
Inclusion Criteria 1. Subjects greater than 18 years old with prostate cancer 2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer 3. Subjects must have clinical stage T…
Contacts

Edward Soffen, MD

(732)-357-2623

edward.soffen@asterahealthcare.org

CONTACT

Heba Darwish

Heba.Darwish@procure.com

CONTACT