Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06591819

Hypofractionated WPPT With HDR Boost

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-02-05

30

Participants Needed

1

Research Sites

567 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase II study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.

CONDITIONS

Official Title

Hypofractionated WPPT With HDR Boost

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologic evidence of prostate cancer
  • High risk or unfavorable intermediate risk prostate cancer as defined by specific tumor stage, Gleason Grade Group, or PSA levels
  • Appropriate for whole pelvis treatment per oncologist or lymph node risk nomogram
  • Candidate for definitive external beam radiotherapy with no prior radiation in the treatment area
  • No inflammatory bowel disease or active collagen/vascular/connective tissue disorders
  • Age 18 years or older
  • ECOG performance status of 0 to 2
  • May have started androgen deprivation therapy up to 3 months before radiation or up to 3 months after radiation starts
  • Completed pretreatment evaluations including history and physical exam, prostate MRI, PSMA PET, and PSA level within 6 weeks prior to enrollment
  • Eligible for rectal spacer procedure
  • Able and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Evidence of distant metastatic disease
  • History of inflammatory bowel disease or active collagen/vascular/connective tissue disorders
  • Prior radiation therapy to the pelvis
  • Prior or concurrent invasive second malignancy except non-melanoma skin cancer unless disease-free for at least five years
  • Severe active co-morbidities that may interfere with study completion or safety
  • Prior history of transurethral resection of the prostate (TURP)
  • Pre-treatment International Prostate Symptom Score (IPSS) greater than 20 or on maximum alpha-blocker medications at baseline
  • Use of therapeutic anticoagulation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

P

Project Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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