Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) with High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
Investigating Tolerability of Combined Radiation Treatments for Prostate Cancer
Omar Ishaq
Primary Investigator
Brief description of study
The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods. Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).
Detailed description of study
The doctor places highly radioactive material inside your body for a short time and then takes it out using a remote control. By combining these two types of radiation therapy, the length of treatment is shortened from 5 weeks of daily external beam radiation to about 1.5 weeks with radiation treatments every other day and both forms of radiation remain within the current FDA approved parameters for treatment. Dual therapy radiation (using internal and external forms of radiation) has also shown promise to produce the same reduction in cancer while reducing the time of lengthy treatment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Prostate cancer
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Age: 18 years - 100 years
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Gender: Male
Inclusion Criteria
- ≥ 18 years old at the time of informed consent
- Capable of providing informed consent and HIPAA authorization
- Karnofsky performance score ≥ 70
- Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
- Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
- Up to date colon cancer screen per American Cancer Society guidelines
Exclusion Criteria
- Prior pelvic irradiation treatment
- Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
- Evidence of nodal or distant disease on screening diagnostic work up.
- Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
- International Prostate Symptom Score (IPSS) score > 16 despite medical therapy
This study investigates the tolerability and side effects of combining two types of radiation therapy for prostate cancer. The first is Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is a type of external beam radiotherapy. The second is High Dose Rate Brachytherapy Boost, a form of internal radiation where a doctor places a small tube or balloon inside the tumor to deliver radiation.
Participants will receive radiation treatments every other day for about 1.5 weeks. This approach combines internal and external radiation to shorten the treatment duration from 5 weeks to 1.5 weeks. The radioactive material is placed inside the body temporarily and removed using a remote control. This dual therapy approach remains within FDA approved treatment parameters.
- Who can participate: Adults 18 years or older with certain types of prostate cancer can join. They need a Karnofsky score of 70+ and should be eligible for the brachytherapy boost.
- Study details: Participants will receive both external and internal radiation treatments. The internal method uses a tube or balloon in the tumor to give high radiation doses briefly.
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