Hypofractionated Radiosurgery for Localised Prostate Cancer

Prostate Cancer Clinical Trial

— HYPOSTAT  

Official title:

Hypofractionated Radiosurgery for Localised Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635256
• Other study ID #: ZKS-121-003
• Secondary ID: ARO-2016-5
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 31, 2019

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, 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%.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

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	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	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, 

References & Publications (2)

Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2. — View Citation

Krug D, Imhoff D, Haidenberger A, Hessler N, Schafer J, Huttenlocher S, Chatzikonstantinou G, Furweger C, Ramm U, Konig IR, Chun F, Staehler M, Rodel C, Muacevic A, Vonthein R, Dunst J, Blanck O. Robotic stereotactic body radiotherapy for localized prosta — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score		12-15 months after radiotherapy
Secondary	Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.		through study completion
Secondary	Prostate Specific Antigen (PSA)		At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
Secondary	International Prostate Symptom Score (IPSS)		Screening and 3, 6-9 and 12-15 months after radiotherapy
Secondary	EORTC Quality of Life Questionnaire (QLQ) C30		At the time of inclusion and 12-15 months after radiotherapy