Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) with High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer

O
Omar Ishaq

Primary Investigator

Enrolling By Invitation
18 years - 100 years
Male
Phase N/A
28 participants needed
1 Location

Brief description of study

What is the purpose of this 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). 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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate cancer
  • Age: 18 years - 100 years
  • Gender: Male

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
  6. Up to date colon cancer screen per American Cancer Society guidelines

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

Updated on 26 Nov 2024. Study ID: CTO-IUSCCC-0832, 21137
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