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Eligibility
for males ages 18 years and up
Dates
study started
estimated completion:

Description

Summary

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.

Official Title

Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer

Keywords

Prostate Cancer

Eligibility

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.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Albert J. Chang
ID
NCT02546427
Phase
Phase 1
Study Type
Interventional
Last Updated
November 1, 2016
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