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Prostate CancerPhase 2NCT06591819

Hypofractionated WPPT With HDR Boost

A Phase 2 study testing Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
15 Jan 2025to Dec 2035
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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);

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Project Manager contact

215-662-3790

RadOncCRU@PennMedicine.upenn.edu

United States1 site, 1 recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Project Manager, 215-662-3790, RadOncCRU@pennmedicine.upenn.edu

    Arun Goel, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Prostate Cancer
Being tested
Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy BoostRadiation

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

Study groups in NCT06591819
Study groupRoleWhat they receive
TreatmentExperimentalThe 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.
Receives: Radiation: Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First year of treatment

Secondary outcomes (2)

  1. 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.

    Measured: First year of treatment

  2. 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.

    Measured: First year of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start15 Jan 2025
  3. Primary completionJan 2034 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06591819
Sponsor's protocol ID
UPCC 08824
Other IDs
855972
Status last verified
Feb 2026
First submitted
3 Sep 2024
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Project Manager (215-662-3790, RadOncCRU@PennMedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of ultrahypofractionated proton therapy with HDR brachytherapy boost (time frame: First year of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06591819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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