Proton therapy with a brachytherapy boost for high-risk prostate cancer
Safety of Hypofractionated Whole-Pelvis Proton Therapy With HDR Boost
This study is testing a new way to treat high-risk prostate cancer using a special type of radiation therapy combined with a targeted boost to see if it works better and causes less harm to healthy tissue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06591819 on ClinicalTrials.gov |
What this trial studies
This phase II study investigates the effectiveness of ultrahypofractionated whole pelvis proton therapy combined with a brachytherapy boost for patients diagnosed with high-risk or unfavorable intermediate-risk prostate cancer. The approach aims to target the prostate and surrounding lymph nodes to improve treatment outcomes while minimizing damage to healthy tissue. Eligible patients will receive this innovative treatment regimen, which is designed to enhance the precision and efficacy of radiation therapy for prostate cancer. The study will assess the safety and effectiveness of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older with pathologically confirmed high-risk or unfavorable intermediate-risk prostate cancer.
Not a fit: Patients with prior radiotherapy in the treatment area or those with certain inflammatory or connective tissue disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and targeted approach to managing high-risk prostate cancer, potentially improving patient outcomes.
How similar studies have performed: While there is ongoing research in the field of proton therapy for prostate cancer, this specific combination of ultrahypofractionated therapy with a brachytherapy boost is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Arun Goel, MD — University of Pennsylvania
- Study coordinator: Project Manager
- Email: RadOncCRU@PennMedicine.upenn.edu
- Phone: 215-662-3790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.