Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT)

• ClinicalTrials.gov Identifier: NCT02635256
• Recruitment Status: Completed
• First Posted: December 18, 2015
• Last Update Posted: January 30, 2020
• Sponsor: University Hospital Schleswig-Holstein
• 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: December 8, 2015
• First Posted Date: December 18, 2015
• Last Update Posted Date: January 30, 2020
• Actual Study Start Date: December 2015
• Actual Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Hypofractionated Radiosurgery for Localised Prostate Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

Radiation: Hypofractionated Radiosurgery

Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife

Study Arms

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, 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 15, 2015): 85
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 31, 2019
• Actual Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02635256
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Juergen Dunst, Prof., University Hospital Schleswig-Holstein
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Schleswig-Holstein
• Original Study Sponsor: Same as current

Collaborators

• University of Luebeck
• Saphir Radiosurgery Center Northern Germany

Investigators

• Principal Investigator: Juergen Dunst, Prof.; University Hospital Schleswig-Holstein

• PRS Account: University Hospital Schleswig-Holstein
• Verification Date: January 2020