Status:
ACTIVE_NOT_RECRUITING
SPORT High-Risk Trial Evaluating SABR in Prostate Cancer
Lead Sponsor:
Belfast Health and Social Care Trust
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on l...
Detailed Description
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on l...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed prostate adenocarcinoma who elect for radical radiotherapy, with at least one of the following features:
- clinical stage T3a N0 M0
- Gleason score 7 (4+3) or above
- PSA \> 20
- No evidence of nodal or distant metastatic disease
- WHO performance status 0-2
- Life expectancy of at least 5 years
- Men greater than or equal to 18 years
- Ability to understand and willingness to sign a written informed consent document (completed prior to registration and subsequent randomization), along with willingness to co-operate with follow-up
- Planned to receive 12-36 months of ADT as part of standard treatment
Exclusion
- T stage greater than or equal to T3b / T4
- Prostate volume \> 90cc
- Current evidence of:
- inflammatory bowel disease or other chronic bowel disorder
- Autoimmune disease
- Active uncontrolled bacterial, viral or fungal infection
- Serious uncontrolled concomitant disease
- Known coagulopathy or bleeding diasthesis
- Anticoagulation medication (if unsafe to insert for seed insertion)
- Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration
- Concurrent experimental or cytotoxic drugs
- Allergy to gold
- Severe lower urinary tract symptoms - International Prostate Symptom Score (IPSS) \> 19
- Any other contra-indication to hormonal therapy or radical radiotherapy.
- History of:
- Previous major abdominal surgery or history of bowel adhesions
- Prior pelvic radiotherapy
- Active malignancy within the preceding five years (other than basal cell carcinoma)
- Evidence of:
- \- Castrate-resistance (rising PSA with castrate levels of testosterone on LHRHa and anti-androgen)
Key Trial Info
Start Date :
January 18 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03253978
Start Date
January 18 2016
End Date
April 30 2026
Last Update
September 7 2023
Active Locations (1)
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1
Belfast Health and Social Care Trust
Belfast, Co. Antrim, United Kingdom, BT9 7AB