Clinical trial NCT02635256: Hypofractionated Radiosurgery for Localised Prostate Cancer
Official title: Hypofractionated Radiosurgery for Localised Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: hypofractionation
prostate cancer
radiotherapy
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Luebeck
name: Saphir Radiosurgery Center Northern Germany
First posted: 2015-12-18
Enrollment: 85
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
timeFrame: 12-15 months after radiotherapy
Secondary outcomes:
measure: Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
timeFrame: through study completion
measure: Prostate Specific Antigen (PSA)
timeFrame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
measure: International Prostate Symptom Score (IPSS)
timeFrame: Screening and 3, 6-9 and 12-15 months after radiotherapy
measure: EORTC Quality of Life Questionnaire (QLQ) C30
timeFrame: At the time of inclusion and 12-15 months after radiotherapy
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Saphir Radiosurgery Center Frankfurt am Main
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt, Department of Radiation Therapy and Oncology
city: Güstrow
country: Germany
facility: Saphir Radiosurgery Center Northern Germany
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein
city: Munich
country: Germany
facility: European Cyberknife Center Munich
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Juergen Dunst, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 prostate cancer: final analysis of the German HYPOSTAT trial. Strahlenther Onkol. 2023 Jun;199(6):565-573. doi: 10.1007/s00066-023-02044-2. Epub 2023 Feb 9.