Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)
18 Years
N/A
Male
Prostate Cancer
Trial Information
Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)
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.
Inclusion Criteria:
- Informed consent signed (Appendix A)
- Adult men greater than 18 years of age
- Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally
reviewed).
- Clinical stage T1-T2b, Gleason Score < 6, and PSA < 10 ng/mL
- Less than 50% of biopsy cores +ve for cancer
- Less than 50% overall surface area involved with cancer
- Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been
performed within 2 months of starting androgen suppression therapy. If androgen
suppression therapy has been started LHRH agonist must be continued for a minimum of
3 months before initiation of gold fiducial marker insertion & radiotherapy planning.
Exclusion Criteria:
- Prior pelvic radiotherapy.
- Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed
insertion)
- Diagnosis of bleeding diathesis
- Presence of a hip prosthesis
- Pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging
device)
- Large prostate (> 60 cm3) on imaging
- Severe lower urinary tract symptoms (International Prostate Symptom Score > 15 or
nocturia > 3)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of grade 3+ rectal toxicity
Outcome Description:
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Outcome Time Frame:
Acute period (up to 6 months)
Safety Issue:
Yes
Principal Investigator
Andrew Loblaw, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sunnybrook Health Sciences Centre
Authority:
Canada: Health Canada
Study ID:
1002-2006
NCT ID:
NCT01578902
Start Date:
October 2006
Completion Date:
October 2013
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
- Radiotherapy
- Hypofractionation
- Low Risk Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|
