Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 83 of 1439 for:    prostate cancer AND radiation

Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer (PHART6)

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.
 
ClinicalTrials.gov Identifier: NCT01146340
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Canadian Association of Radiation Oncology
Information provided by (Responsible Party):
Andrew Loblaw, Sunnybrook Health Sciences Centre

Brief Summary:
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Hypofractionated radiotherapy Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
Study Start Date : May 2010
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SBRT
SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
Radiation: Hypofractionated radiotherapy
40 Gy / 5 fractions / 29 days




Primary Outcome Measures :
  1. Incidence of grade 3+ rectal toxicity [ Time Frame: Acute period (<3 months) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0


Secondary Outcome Measures :
  1. Incidence of grade 3+ urinary toxicity [ Time Frame: Acute (<3 months) and Late (>6 months) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

  2. Quality of Life [ Time Frame: 5 years ]
    Expanded Prostate Cancer Index Composite (EPIC)

  3. Biochemical (ie. prostate specific antigen) disease free survival [ Time Frame: 5 year ]
  4. Incidence of grade 3+ rectal toxicity [ Time Frame: Late (>6 months) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Men >18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Presence of a hip prosthesis
  • Pelvic girth >40cm - Large prostate (>90cm3) on imaging
  • Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146340


Locations
Layout table for location information
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Association of Radiation Oncology
Investigators
Layout table for investigator information
Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre
Principal Investigator: Harvey Quon, MD Sunnybrook Health Sciences Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andrew Loblaw, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01146340     History of Changes
Other Study ID Numbers: 042-2010
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Andrew Loblaw, Sunnybrook Health Sciences Centre:
Prostatic Neoplasms
Radiotherapy
Hypofractionation
Low and Intermediate Risk Prostate Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases