Prostate Cancer
Conditions
Keywords
SBRT (stereotactic body radiotherapy), Focal boost, Prostate
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.
Interventions
RADIATIONRadiotherapy
Stereotactic body radiotherapy (SBRT) to the whole prostate (36.25 Gy in 5 fractions) with a focal boost (47.5 Gy in 5 fractions) to the MRI-defined dominant tumour nodule.
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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 * PSA\>40 * Stage T3b or higher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute genitourinary(GU) toxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| Acute gastrointestinal (GI) toxicity | Within 12 weeks of treatment completion | RTOG scale |
| Late GI and GU toxicity | From 12 weeks until study completion | RTOG scale |
| Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D | Baseline, 12 weeks, 12 months and 6 monthly to 5 years | IPSS, IIEF-5 and EQ5-D |
| Biochemical relapse-free survival | Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter | PSA will be measured 3-6 monthly during study |
Countries
United Kingdom
Contacts
Primary ContactNicholas J van As, FRCR
Backup ContactDaniel R Henderson, FRCR
Outcome results
None listed