Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital Schleswig-Holstein
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
Gleason-grade ≤7, ISUP Grade Group 1-3
Guideline-based staging
Age ≥ 18 years
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Hypofractionated Radiosurgery
RadiationImage-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Treatment groups
175 Participants
are divided into 1 treatment groupGroup A: Hypofractionated RadiosurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
GU and GI Toxicity
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Time frame
12-15 months after radiotherapySecondary outcomes
1
Acute toxicity
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Time frame
Through study completion2
PSA
Prostate Specific Antigen (PSA)
Time frame
At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy3
IPSS
International Prostate Symptom Score (IPSS) on a scale 0-35 with lower being better
Time frame
Screening and 3, 6-9 and 12-15 months after radiotherapy4
Quality of Life Score
EORTC Quality of Life Questionnaire (QLQ) C30 on a scale 0-100 with higher being better
Time frame
At the time of inclusion and 12-15 months after radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Schleswig-Holstein
Lead sponsor
University of Luebeck
Collaborator
Source ClinicalTrials.gov