Prostate Cancer
Conditions
Keywords
Hypofractionation, Prostate Cancer, Radiotherapy, long-term toxicity
Brief summary
Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible. Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.
Detailed description
Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy). Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).
Interventions
RADIATIONHypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with dedicated radiosurgery system such as CyberKnife
Sponsors
University of Luebeck
Saphir Radiosurgery Center Northern Germany
University Hospital Schleswig-Holstein
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0 * Gleason-grade ≤7 * Guideline-based staging * Age ≥ 60 years * PSA \< 15 ng / ml * Volume of the prostate \< 80 cm³ * IPSS-Score ≤ 12 * Written informed consent
Exclusion criteria
* Age ≤ 60 years * History of prior pelvic radiotherapy * Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold), * Immunosuppressive therapy * Relevant comorbidity thought to adversely affect treatment compliance, * Legal incapacity or lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score | 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. | 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
| Prostate Specific Antigen (PSA) | At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
| International Prostate Symptom Score (IPSS) | At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
| EORTC Quality of Life Questionnaire (QLQ) C30 | At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
Countries
Germany
Outcome results
None listed