Evaluating a new radiation therapy approach for prostate cancer
Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
NA · Indiana University · NCT06817668
This study is testing a new way of giving radiation treatment for prostate cancer to see if combining two methods can help patients feel better with fewer side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Indiana University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06817668 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the tolerability and toxicity of a combined radiation therapy approach for prostate cancer, utilizing Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) alongside a High Dose Rate Brachytherapy Boost. The methodology involves delivering a specific radiation dose through external beam therapy followed by an internal radiation boost to enhance treatment efficacy. The goal is to determine if this dual therapy can improve patient outcomes while minimizing side effects.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with pathologically confirmed unfavorable intermediate, high, or very high-risk prostate cancer who are planning to undergo standard brachytherapy.
Not a fit: Patients with prior pelvic irradiation treatment or those with evidence of nodal or distant disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for patients with prostate cancer.
How similar studies have performed: Previous studies have shown that combining external beam radiation with brachytherapy can improve survival outcomes, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Capable of providing informed consent and HIPAA authorization 3. Karnofsky performance score ≥ 70 4. Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician 5. Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure Exclusion Criteria: 1. Prior pelvic irradiation treatment 2. Prior rectal surgery which precludes instrumentation with rectal ultrasound probe. 3. Evidence of nodal or distant disease on screening diagnostic work up. 4. Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure 5. International Prostate Symptom Score (IPSS) score \> 16 despite medical therapy
Where this trial is running
Indianapolis, Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Omar Ishaq, MD — Indiana University Simon Comprehensive Cancer Center
- Study coordinator: Omar Ishaq, MD
- Email: oishaq@iuhealth.org
- Phone: 317-944-2524
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.
Conditions: Prostate Cancer, Brachytherapy boost