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Trial details

5 Fractions of Pelvic SABR with Intra prostatic SABR Boost: A Phase II Study

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Trial short name: 5STAR (PHART 14)

Official title: 5 Fractions of Pelvic SABR with Intra prostatic SABR Boost: A Phase II Study

Principal Investigator: Dr. Andrew Loblaw

Cancer type: Genitourinary
Cancer location: Genitourinary
Disease stage: Early Cancer
Trial phase:
Intervention:

Registration #:

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Inclusion Criteria -Histologically confirmed prostate adenocarcinoma (centrally reviewed) -HIRPC defined as: PSA 10-20ng/ml AND (T2b-2c OR Gleason 7) -HRPC, defined as at least one of: T3, OR Gleason 8-10, OR PSA > 20 ng/mL -Willing to give informed consent to participate in this clinical trial -Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire Exclusion Criteria -Prior pelvic radiotherapy -Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease -Contraindication to prostate MRI -Anticoagulation medication (if unsafe to discontinue for gold seed insertion) -Diagnosis of bleeding diathesis -Hip prosthesis -Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT. -Previous TURP -Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20 -Significant medical co-morbidity rendering patient unsuitable for general anesthetic -No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. -Definitive extrapelvic nodal or distant metastatic disease on staging investigations.