Prostate Cancer Clinical Trial
— SPORTOfficial title:
A Randomised Feasibility Study Evaluating Stereotactic Prostate Radiotherapy In High-Risk Localised Prostate Cancer With or Without Elective Nodal Irradiation
Verified date | September 2023 |
Source | Belfast Health and Social Care Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 levels of markers of radiation exposure and bowel damage, along with other potential markers of outcome and side effects. Quality of life and any side effects that develop during and after treatment will also be assessed.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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 Criteria: 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast | Co. Antrim |
Lead Sponsor | Collaborator |
---|---|
Belfast Health and Social Care Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequate recruitment rate | adequate recruitment rate (30 patients in 24 months) | 24 months | |
Primary | Acute toxicity of SABR | Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR) | 90 days of completion of SABR | |
Primary | Acute quality of life during and after SABR | Acute quality of life during and after SABR (as assessed by EPIC and IPSS scores until 90 days after completion of SABR) | 90 days after completion of SABR | |
Primary | Number of SABR plans delivered as planned and on schedule | Number of SABR plans delivered as planned and on schedule | 29 days (treatment period) | |
Primary | Quantification of acute toxicity in each treatment group | Quantification of acute toxicity in each treatment group to enable calculation of the sample size for the Phase II RCT (using CTCAE v4.03 scores measured until 90days post completion of radiotherapy) | until 90 days post completion of radiotherapy | |
Secondary | Late toxicity of SABR | Late toxicity of SABR (as assessed by GI and GU RTOG late toxicity scores from 90 days to ten years post completion of SABR) | from 90 days and up to ten years post completion of SABR | |
Secondary | Late patient-reported quality of life | Late patient-reported quality of life (as assessed by EPIC and IPSS scores from 90 days to ten years post completion of SABR) | up to ten years post completion of SABR | |
Secondary | Rate of PSA failure | Rate of PSA failure as assessed by Phoenix criteria | up to ten years post completion of SABR | |
Secondary | Prostate cancer-specific survival | Prostate cancer-specific survival | up to ten years post completion of SABR | |
Secondary | Overall survival | Overall survival | up to ten years post completion of SABR |
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