5STAR: 5 Fractions of Pelvic SABR With Intra Prostatic SABR
Study Details
Study Description
Brief Summary
Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1 Pelvic SABR with intra-prostatic SABR |
Radiation: Pelvic SABR with intra-prostatic SABR
described elsewhere
|
Outcome Measures
Primary Outcome Measures
- To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria [3 months after accrual target is reached]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed prostate adenocarcinoma (centrally reviewed)
-
High- tier intermediate risk defined as:
PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )
• High-risk prostate cancer, 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
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Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
Exclusion Criteria:
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Prior pelvic radiotherapy
-
Contra-indication 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)
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Diagnosis of bleeding diathesis
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Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
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Previous TURP
-
Poor baseline urinary function defined as International Prostate Symptom Score (IPSS)
20
-
Significant medical co-morbidity rendering patient unsuitable for general anesthetic
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Andrew Loblaw
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 360-2016