Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

Prostate Cancer Clinical Trial

— HYPOSTAT-II  

Official title:

Hypofractionated Radiosurgery for Localised Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03795337
• Other study ID #: ZKS-121-08
• Secondary ID: ARO-2018-4
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 475
• Est. completion date: December 31, 2025
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife

Locations

Country	Name	City	State
Germany	Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)	Berlin
Germany	University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy	Cologne
Germany	CyberKnife Centrum Mitteldeutschland	Erfurt
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	Kiel
Germany	University Medical Center Schleswig-Holstein	Kiel
Germany	European Cyberknife Center Munich	Munich

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	Saphir Radiosurgery Center Northern Germany, University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	EORTC Quality of Life Questionnaire (QLQ) C30		At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy