low-risk prostate cancer prostate carcinoma
Conditions
Interventions
All patients will be treated with HDR-BT in a single fraction. In phase I
fraction doses will be 19, 19.5 and 20 Gy for consecutive groups. Phase II will
continue with the RDL of phase I.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men aged 18-80 years Histological confirmation of prostate adenocarcinoma Gleason score * 7 Clinical stage T1c-T2a, N0-X, M0 PSA * 15 ng/ml WHO performance status 0-2 Prostate volume * 50 ml IPSS score * 12 Maximum urinary flow rate * 15 ml/s at uroflowmetry and residual volume of
Exclusion criteria
Exclusion criteria: Previous malignancy within the last 5 years, except basal cell carcinoma or squamous cell carcinoma of the skin In case of Gleason score 7: more than 3 positive biopsies Prior pelvic radiotherapy Prior androgen deprivation therapy (including androgen agonists and antagonists) Any prior active treatment for prostate cancer (Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria) Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In phase I the incidence of acute (up to 3 months after treatment) gastrointestinal (GI) and genitourinary (GU) toxicity grade 3 or higher will be determined for each dose level. In phase II the acute and one-year late toxicity incidences will be evaluated as primary endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be biochemical recurrence rate, disease specific survival and quality of life. | — |
Countries
Netherlands
Outcome results
None listed