Recruiting
Phase 2

Hypofractionated WPPT

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06591819

Conditions

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost

Study Details

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

Study ID

NCT06591819

Start date

Jan 15, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Jan, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost

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

Primary outcome measure

  • Safety of ultrahypofractionated proton therapy with HDR brachytherapy boost [ Time Frame: First year of treatment ]

Central Contacts and Locations

Central contacts

Project Manager

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Project Manager

215-662-3790RadOncCRU@pennmedicine.upenn.edu

Principal Investigator:

Arun Goel, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-02-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.