An interventional study of Hypofractionated Radiosurgery in Prostate Cancer, sponsored by University Hospital Schleswig-Holstein. Active, not recruiting at 8 sites in Germany. Open to male participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Treatment
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.
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 475 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5 fractions with 7 Gy, total dose 35 Gy
Radiation: Hypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Time frame: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
Time frame: 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
Prostate Specific Antigen (PSA)
Time frame: 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)
Time frame: 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
Time frame: At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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University Hospital Schleswig-Holstein