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NCT Number: NCT06591819

Hypofractionated WPPT 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Arun Goel, MD

PRINCIPAL_INVESTIGATOR

Project Manager

CONTACT

[email protected]

215-662-3790

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost

Radiation

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

Primary outcomes

  1. Safety of ultrahypofractionated proton therapy with HDR brachytherapy boost

    Time frame: First year of treatment

    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.

Secondary outcomes

  1. Quality of life before and after radiotherapy

    Time frame: First year of treatment

    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.

  2. Efficacy of proton radiotherapy

    Time frame: First year of treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Project Manager

CONTACT

[email protected]

215-662-3790

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Safety of Hypofractionated Whole-Pelvis Proton Therapy With HDR Boost

Important dates

Study start
2025
Primary completion
2034
Study completion
2035
First posted
Sep 19, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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