Hypofractionated WPPT With HDR Boost

NCT06591819 | Recruiting Phase 2 FDA Device

• 2 other identifiers: UPCC 08824855972
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of life before and after radiotherapy

  First year of treatment

• Efficacy of proton radiotherapy

  First year of treatment

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost RADIATION

Brachytherapy boost will be delivered and then whole pelvis proton radiation therapy in 5 fractions.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Arun Goel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

215-662-3790; RadOncCRU@PennMedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): December 1, 2035
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)