Trial record 1 of 1 for:    NCT02546427
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Hypofractionated Whole Pelvic Radiotherapy of the Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02546427
Recruitment Status : Withdrawn (PI left UCSF and the study was closed without any accruals.)
First Posted : September 10, 2015
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
Albert J. Chang, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Helical TomoTherapy (HT) Radiation: CyberKnife SBRT Radiation: Permanent Prostate Implant (PPI) Radiation: HDR brachytherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer
Actual Study Start Date : December 9, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment

Step 1: Pelvic Lymph Node Irradiation

Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each

Step 2: Treat boost volume to prostate and seminal vesicles

Acceptable treatment modalities:

CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT

Permanent prostate implant (PPI):

108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR

Radiation: Helical TomoTherapy (HT)
Radiation: CyberKnife SBRT
Radiation: Permanent Prostate Implant (PPI)
Radiation: HDR brachytherapy

Primary Outcome Measures :
  1. Toxicity [ Time Frame: 90 days post treatment ]
    Acute G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4

Secondary Outcome Measures :
  1. Late Toxicity [ Time Frame: From 90 days post treatment until 36 months from start of therapy ]
    G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4

  2. High-Related Quality of Life (HRQOL) [ Time Frame: Baseline, week prior to RT, 6 weeks post treatment, and at least every 6 months for the first 2 years. ]
    EPIC-26 Questionnaire

  3. PSA Complete Response (PSA-CR) [ Time Frame: 120-127 days after initiation of therapy ]
    Via PSA laboratory with PSA level ≤0.3

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Responsible Party: Albert J. Chang, Assistant Professor, University of California, San Francisco Identifier: NCT02546427     History of Changes
Other Study ID Numbers: 15551
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases