Hypofractionated WPPT With HDR Boost

Safety of Hypofractionated Whole-Pelvis Proton Therapy With HDR Boost

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: 215-662-3790; Email: RadOncCRU@PennMedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Project Manager; Phone Number: 215-662-3790; Email: RadOncCRU@PennMedicine.upenn.edu
      • Principal Investigator: Arun Goel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologic evidence of prostate cancer

• Risk group: high or intermediate risk as defined below

  • High risk: T3a or Gleason Grade Group 4/5 or PSA >20
  • Unfavorable intermediate risk disease: at least one or more of the following: T2b-T2c, Gleason Grade Group 2/3, PSA 10-20, >50% of cores positive
• Must be appropriate for whole pelvis per the treating oncologist or based on lymph node predicting nomogram

• Patient is a candidate for definitive external beam radiotherapy:

  • No prior radiotherapy in the region of study
  • No inflammatory bowel disease, active collagen/vascular/connective tissue disorders
• Age ³18 years
• ECOG performance status: 0-2
• Patients may initiate androgen deprivation therapy up to 3 months prior to radiation start, concurrently, or up to 3 months after completion of radiation therapy start. Patients may have received androgen deprivation therapy for the following months: unfavorable intermediate risk patients for 6 months; high-risk patients for 24 months. Patients will be allowed to discontinue ADT at physician and patient discretion.

• Pretreatment evaluation

  • History & Physical by a radiation oncologist within 6 weeks of enrollment
  • MRI prostate
  • PSMA PET
  • PSA level
• Eligible for rectal spacer procedure as determined by treating physician
• Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility);

Exclusion Criteria:

• Evidence of distant metastatic disease
• History of inflammatory bowel or active collagen/vascular/connective tissue disorders
• Prior radiation to the pelvis
• Prior or concurrent second invasive malignancy other than non-melanoma skin cancers, unless disease free for minimum of five years

• Known severe, active co-morbidity, defined as follows:

  o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results.

• Patients should not have a prior history of TURP
• Patients should not have pre-treatment IPSS >20 or on maximum alpha-blocker medications at baseline
• Patients should not be on therapeutic anticoagulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; The standard treatment for patients with prostate cancer is to receive brachytherapy boost and then radiation therapy in 25 fractions. This research study is being conducted to see how safe and effective delivering brachytherapy boost and then whole pelvis proton radiation therapy in 5 fractions (with each fraction having a higher dose than each fraction in the standard treatment) is in treating patients with prostate cancer. Subjects will also be asked to complete quality of life questionnaires for this study.

Radiation: Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost; Brachytherapy boost will be delivered and then whole pelvis proton radiation therapy in 5 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of ultrahypofractionated proton therapy with HDR brachytherapy boost	The technique will be deemed safe if <10% of patients experience a CTCAE version 5.0 grade 3 or higher genitourinary or gastrointestinal toxicity cumulatively.	First year of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life before and after radiotherapy	To evaluate for multiple domains of quality of life before and after radiotherapy by using validated surveys including EPIC-26 in urinary continence, urinary obstruction, bowel, and sexual domains. Investigators will determine minimally important differences for each domain.	First year of treatment
Efficacy of proton radiotherapy	To determine treatment efficacy of proton radiotherapy for all enrolled patients as evidenced by biochemical control in the months following radiation. Investigators will follow PSA to determine if there is evidence for biochemical recurrence following radiotherapy. PSA recurrence will be defined as an increase of 2 ng/ml higher than the nadir value following completion of radiotherapy.	First year of treatment

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Arun Goel, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UPCC 08824; 855972 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No