Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART3)
|ClinicalTrials.gov Identifier: NCT01578902|
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Hypofractionated radiotherapy||Phase 1 Phase 2|
Rationale for Proposed Study With the availability of intensity modulated radiotherapy (IMRT) at the Odette Cancer Centre (OCC), there is an opportunity to explore the use of a much more intensive hypofractionation schedule for prostate cancer. Using an alpha/beta ratio of 1.3, a dose of 35 Gy in 5 fractions would be equivalent to 88 Gy delivered in 2 Gy fractions. For normal tissues (alpha/beta value of 2), this would be equivalent to 78 Gy in 2 Gy fractions. As such, the linear quadratic equation predicts that 35 Gy in 5 fractions should not result in any increased late toxicity for normal tissues compared to standard dose escalated radiotherapy. However, the biological dose to the prostate cancer would be significantly increased. As a safety precaution for this study proposal, the investigators propose to deliver 35 Gy in 5 fractions over 5 weeks (one radiotherapy fraction of 7 Gy per week) to allow for normal tissue repair.
With IMRT, it is expected that there will be superior conformality of the high dose region around the target volume. As well, the use of daily on-line imaging will allow us to eliminate interfraction prostate motion errors and use tighter planning target volume margins for any residual intrafraction motion. At OCC, such an approach has already been shown to be feasible and is currently employed in the phase 1/2 concomitant boost study for high risk prostate cancer.
If proven to be safe and effective, such a hypofractionated radiotherapy schedule may have significant practical advantages as well. With only 1 fraction of radiotherapy delivered each week (for a total of 5 weeks), there are huge savings in resource utilization and increased convenience for patients.
The investigators propose to start a small phase 1 study to explore the use of this dose fractionation for men with low risk prostate cancer. The primary endpoint for this small pilot study would be acute and late normal tissue toxicities. If proven to be feasible and safe, external peer-reviewed funding will be sought to further explore this novel treatment schedule in a larger phase 2 setting.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2013|
Experimental: Hypofractionated radiation
35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.
Radiation: Hypofractionated radiotherapy
35Gy/5 fractions/29 days
Other Name: standard linear accelerator delivery
- Incidence of grade 3+ rectal toxicity [ Time Frame: Acute period (up to 6 months) ]Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- Incidence of grade 3+ urinary toxicity [ Time Frame: Acute (up to 6 months) and Late (6 months and after) ]Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- Incidence of grade 3+ rectal and urinary toxicity [ Time Frame: Late (6 months and after) ]Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- Quality of Life [ Time Frame: up to 5 years ]Expanded Prostate Cancer Index Composite (EPIC)
- Biochemical (ie. prostate specific antigen) disease free survival [ Time Frame: 5 year ]
- Biopsy positive rate [ Time Frame: 3 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578902
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Andrew Loblaw, MD||Sunnybrook Health Sciences Centre|
|Principal Investigator:||Patrick Cheung, MD||Sunnybrook Health Sciences Centre|