Stereotactic Prostate Augmented Radiotherapy With Cyberknife
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Royal Marsden NHS Foundation Trust
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Acute genitourinary(GU) toxicity
- Last Updated
- 11 years ago
Overview
Brief Summary
Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.
Detailed Description
Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland. Primary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS)) Secondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale) Inclusion criteria * Prostate cancer patients with any of the following: * PSA\>20 * Gleason grade 4+3 or higher * Stage T3a * Exclusion criteria * Nodal or metastatic disease * PSA\>40 * Stage T3b or higher Study interventions This is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 Gy in 5 fractions or to the highest dose possible within dose constraints. The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Prostate cancer patients with any of the following:
- •PSA 20-40
- •Gleason grade 4+3 or higher
- •Stage T3a
Exclusion Criteria
- •Nodal or metastatic disease
- •Stage T3b or higher
Outcomes
Primary Outcomes
Acute genitourinary(GU) toxicity
Time Frame: Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)
RTOG scale acute GU toxicity will be measured at baseline, end of treatment, then 2,4 and 12 weeks post treatment. The maximal toxicity during follow up is the primary outcome measure.
Secondary Outcomes
- Acute gastrointestinal (GI) toxicity(Within 12 weeks of treatment completion)
- Late GI and GU toxicity(From 12 weeks until study completion)
- Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D(Baseline, 12 weeks, 12 months and 6 monthly to 5 years)
- Biochemical relapse-free survival(Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter)