Hypofractionated Whole Pelvic Radiotherapy of the Prostate
a study on Prostate Cancer
- for males ages 18 years and up
- study startedestimated completion:
This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by NCCN risk criteria. Patients will have>15% risk of lymph node involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated if>30% acute grade 2 or>5% grade 3 or greater toxicity is observed as a result of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.
Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer
You can join if…
Open to males ages 18 years and up
- Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b,PSA>10, and/or Gleason score ≥ 7) who have a greater than 15% risk of lymph node involvement as determined by the Roach equation.
- History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
- Zubrod performance status 0-2
- Age ≥18 years
- Ability to understand a written informed consent document, and the willingness to sign it
You CAN'T join if...
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Patients with history of inflammatory bowel disease or major bowel surgery.
- Prior transurethral resection of the prostate (TURP) procedure.
- not yet accepting patients
- Start Date
- Completion Date
- Albert J. Chang
- Phase 1
- Study Type
- Last Updated
- November 1, 2016
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02546427.