Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer
PHART6
Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started May 2010
Longer than P75 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedOctober 4, 2019
October 1, 2019
5.9 years
June 14, 2010
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Acute period (<3 months)
Secondary Outcomes (4)
Incidence of grade 3+ urinary toxicity
Acute (<3 months) and Late (>6 months)
Quality of Life
5 years
Biochemical (ie. prostate specific antigen) disease free survival
5 year
Incidence of grade 3+ rectal toxicity
Late (>6 months)
Study Arms (1)
SBRT
EXPERIMENTALSBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.
PMID: 27622157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Loblaw, MD
Sunnybrook Health Sciences Centre
- PRINCIPAL INVESTIGATOR
Harvey Quon, MD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
June 14, 2010
First Posted
June 17, 2010
Study Start
May 1, 2010
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
October 4, 2019
Record last verified: 2019-10