Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-10-31
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Pelvic SABR with intra-prostatic SABR
Pelvic SABR with intra-prostatic SABR
described elsewhere
Interventions
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Pelvic SABR with intra-prostatic SABR
described elsewhere
Eligibility Criteria
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Inclusion Criteria
* 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
* Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
Exclusion Criteria
* 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)
* Diagnosis of bleeding diathesis
* 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.
18 Years
99 Years
MALE
No
Sponsors
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Andrew Loblaw
OTHER
Responsible Party
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Andrew Loblaw
Principal investigator
Other Identifiers
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360-2016
Identifier Type: -
Identifier Source: org_study_id