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Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635256
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
University of Luebeck
Saphir Radiosurgery Center Northern Germany
Information provided by (Responsible Party):
Juergen Dunst, Prof., University Hospital Schleswig-Holstein

Tracking Information
First Submitted Date  ICMJE December 8, 2015
First Posted Date  ICMJE December 18, 2015
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score [ Time Frame: 12-15 months after radiotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. [ Time Frame: through study completion ]
  • Prostate Specific Antigen (PSA) [ Time Frame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: Screening and 3, 6-9 and 12-15 months after radiotherapy ]
  • EORTC Quality of Life Questionnaire (QLQ) C30 [ Time Frame: At the time of inclusion and 12-15 months after radiotherapy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. [ Time Frame: During radiotherapy ]
  • Prostate Specific Antigen (PSA) [ Time Frame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: Screening and 3, 6-9 and 12-15 months after radiotherapy ]
  • EORTC Quality of Life Questionnaire (QLQ) C30 [ Time Frame: At the time of inclusion and 12-15 months after radiotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Radiosurgery for Localised Prostate Cancer
Official Title  ICMJE Hypofractionated Radiosurgery for Localised Prostate Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: Hypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Study Arms  ICMJE Experimental: Hypofractionated Radiosurgery
5 fractions with 7 Gy, total dose 35 Gy
Intervention: Radiation: Hypofractionated Radiosurgery
Publications * Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rödel C, Hildebrandt G, Jünemann 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2015)
85
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02635256
Other Study ID Numbers  ICMJE ZKS-121-003
ARO-2016-5 ( Other Identifier: German Cancer Society )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Juergen Dunst, Prof., University Hospital Schleswig-Holstein
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital Schleswig-Holstein
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Luebeck
  • Saphir Radiosurgery Center Northern Germany
Investigators  ICMJE
Principal Investigator: Juergen Dunst, Prof. University Hospital Schleswig-Holstein
PRS Account University Hospital Schleswig-Holstein
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP