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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Albert J. Chang, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02546427
First received: August 27, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Prostate Cancer
Radiation: Helical TomoTherapy (HT)
Radiation: CyberKnife SBRT
Radiation: Permanent Prostate Implant (PPI)
Radiation: HDR brachytherapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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


Secondary Outcome Measures:
  • 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

  • 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

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


Estimated Enrollment: 35
Study Start Date: September 2015
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02546427

Contacts
Contact: Albert Chang, MD 415-353-7175 ChangAJ@RadOnc.ucsf.edu
Contact: Romobia Hutchinson, BS 415-535-4294 Romobia.Hutchinson@ucsf.edu

Sponsors and Collaborators
Albert J. Chang
  More Information

Responsible Party: Albert J. Chang, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02546427     History of Changes
Other Study ID Numbers: 15551
Study First Received: August 27, 2015
Last Updated: November 1, 2016

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

ClinicalTrials.gov processed this record on March 24, 2017