Hypofractionated Radiosurgery for Localised Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Hypofractionated Radiosurgery

• Registration Number: NCT02635256
• Lead Sponsor: University Hospital Schleswig-Holstein

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, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.

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 four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-18
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 85

Inclusion Criteria

• Localised, histopathologically confirmed Prostate Cancer (cT1-3 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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated Radiosurgery	Hypofractionated Radiosurgery	5 fractions with 7 Gy, total dose 35 Gy

Primary Outcome Measures

Name	Time	Method
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score	12-15 months after radiotherapy

Secondary Outcome Measures

Name	Time	Method
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.	through study completion
International Prostate Symptom Score (IPSS)	Screening and 3, 6-9 and 12-15 months after radiotherapy
Prostate Specific Antigen (PSA)	At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
EORTC Quality of Life Questionnaire (QLQ) C30	At the time of inclusion and 12-15 months after radiotherapy

Trial Locations

Locations (5)

University Medical Center Schleswig-Holstein; 🇩🇪 Kiel, Germany

Saphir Radiosurgery Center Frankfurt am Main; 🇩🇪 Frankfurt am Main, Germany

University Hospital Frankfurt, Department of Radiation Therapy and Oncology; 🇩🇪 Frankfurt am Main, Germany

Saphir Radiosurgery Center Northern Germany; 🇩🇪 Güstrow, Germany

European Cyberknife Center Munich; 🇩🇪 Munich, Germany