Prostate CancerCancer of ProstateProstate Adenocarcinoma
Investigational drug(s) / intervention(s)
Stereotactic Ablative Body Radiation
Stereotactic Ablative Body Radiation: 2 Fraction
Study summary
Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Histologically confirmed prostate adenocarcinoma (centrally reviewed)
2. Low or favorable intermediate risk disease. Patient must meet one of the following categories:
* Low risk - T1-T2b, grade group 1, AND PSA \< 10 ng/ml;
* Favorable risk
1. Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
2. Grade group 3 AND PSA \< 20, AND \<cT2c AND absolute percentage pattern 4/5 is \<10%
Exclusion Criteria:
1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
2. Prior pelvic radiotherapy
3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
4. Diagnosis of bleeding diathesis
5. Large prostate (\>90cm3) on imaging
6. Immunosuppressive medications
7. Inflammatory bowel disease
8. Presence of dual hip prostheses
9. Contraindications to having MRI
Primary outcome measure(s)
Prostate Cancer Patient's Quality of Life Function will be measured to determine change in Quality of life function from baseline to 5 years beyond treatment. — Change in patient Quaity of Life will be asseses from Before treatment (Baseline); week 1, 4 and 13; month 6 and every 6 months for 5 years Expanded Prostate Cancer Index Composite questionnaires will be scored and analyzed to determine change in Quality of life function from baseline
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
More Sunnybrook Health Sciences Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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