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Phase II Study: Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost for Prostate Cancer

This study is testing a new way to treat prostate cancer using a combination of radiation therapies. It involves Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost. This treatment delivers radiation to the whole pelvis in 5 sessions, along with an internal radiation boost (brachytherapy). The study is for men aged 18 and older who have prostate cancer that is considered high-risk or unfavorable intermediate-risk. The main goal is to see how safe this new treatment approach is during the first year after treatment. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is a Phase II study, meaning it's an early-stage study looking at safety and effectiveness. It plans to enroll 30 participants.
What's involved
Participants will receive brachytherapy (internal radiation) followed by whole pelvis proton radiation therapy in 5 sessions.
Compensation
Not stated in the trial record.
Follow-up
The safety of the treatment will be measured during the first year after treatment.

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NCT06591819

Hypofractionated WPPT With HDR Boost

Recruiting
PHASE2Ages 18+InterventionalTreatment
Abramson Cancer Center at Penn Medicine
~30 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of ultrahypofractionated proton therapy with HDR brachytherapy boost
Measured over First year of treatment

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Arun Goel, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Project Manager
[email protected]
215-662-3790
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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

What this trial measures

  • Safety of ultrahypofractionated proton therapy with HDR brachytherapy boostFirst 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.