NCT06591819 · Abramson Cancer Center at Penn Medicine
Hypofractionated WPPT With HDR Boost
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations