Prostate Cancer
Conditions
Keywords
Brachytherapy boost
Brief summary
The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: 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
Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.
Interventions
RADIATIONePURT 5Gy x 5 fractions with single HDR boost of 15Gy
ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with acute grade ≥ 2 GU toxicity | 3 months | Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with acute grade ≥ 2 GI toxicity | 3 months | Acute grade ≥ 2 GI toxicity at 3 months post ePUHRT with HDR boost by CTCAE version 5 |
| Percentage of participants with acute grade ≥ 2 GU toxicity | 3 months | Self-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by PRO-CTCAE |
Countries
United States
Contacts
Primary ContactOmar Ishaq, MD
Backup ContactKathy Lauer, BA
Outcome results
None listed