Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

Not Applicable

Active, not recruiting

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

• Registration Number: NCT03795337
• 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 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).

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-07
• Study Start: 2019-03-05
• Status Verified: 2024-03
• Primary Completion: 2024-03-04
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 475

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

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	3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy

Secondary Outcome Measures

Name	Time	Method
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
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
EORTC Quality of Life Questionnaire (QLQ) C30	At the time of inclusion; 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

Trial Locations

Locations (8)

Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK); 🇩🇪 Berlin, Germany

University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy; 🇩🇪 Cologne, Germany

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

CyberKnife Centrum Mitteldeutschland; 🇩🇪 Erfurt, Germany

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

Saphir Radiosurgery Center Northern Germany; 🇩🇪 Kiel, Germany

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

European Cyberknife Center Munich; 🇩🇪 Munich, Germany