Prostate Cancer
Conditions
Keywords
Prostate Cancer, SBRT, CyberKnife, Radiosurgery, HYPOSTAT
Brief summary
Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.
Detailed description
Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading. Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).
Interventions
RADIATIONHypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Sponsors
University Hospital Schleswig-Holstein
University of Luebeck
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0) * Gleason-grade ≤7, ISUP Grade Group 1-3 * Guideline-based staging * Age ≥ 18 years * PSA \< 20 ng/ml * Volume of the prostate \< 80 cm³ * IPSS-Score ≤ 12 * Written informed consent
Exclusion criteria
* History of prior pelvic radiotherapy * Previous transurethral resection, laser enucleation or prostate ablation * Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy) * Relevant comorbidity thought to adversely affect treatment compliance * Legal incapacity or lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GU and GI Toxicity | 12-15 months after radiotherapy | Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | Through study completion | Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports |
| PSA | At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy | Prostate Specific Antigen (PSA) |
| IPSS | Screening and 3, 6-9 and 12-15 months after radiotherapy | International Prostate Symptom Score (IPSS) on a scale 0-35 with lower being better |
| Quality of Life Score | At the time of inclusion and 12-15 months after radiotherapy | EORTC Quality of Life Questionnaire (QLQ) C30 on a scale 0-100 with higher being better |
| Decision Regret Score | At the time of inclusion and 12-15 months after radiotherapy | Decision Regret Score on a scale 0-100 with lower being lower regret |
Countries
Germany
Contacts
CONTACTOliver Blanck, PhD
CONTACTFrauke Walther-Clausnizer
PRINCIPAL_INVESTIGATORDavid Krug, MD
University Hospital Schleswig-Holstein
Outcome results
None listed