Clinical trial NCT06914544: Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Official title: Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
SBRT
CyberKnife
Radiosurgery
HYPOSTAT
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Luebeck
First posted: 2025-04-06
Enrollment: 175
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.

Detailed description: Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.

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-T2c N0 M0)
* Gleason-grade ≤7, ISUP Grade Group 1-3
* Guideline-based staging
* Age ≥ 18 years
* PSA \< 20 ng/ml
* Volume of the prostate \< 80 cm³
* IPSS-Score ≤ 12
* Written informed consent

Exclusion Criteria:

* History of prior pelvic radiotherapy
* Previous transurethral resection, laser enucleation or prostate ablation
* Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
* Relevant comorbidity thought to adversely affect treatment compliance
* Legal incapacity or lack of informed consent

Primary outcomes:
measure: GU and GI Toxicity
timeFrame: 12-15 months after radiotherapy
Secondary outcomes:
measure: Acute toxicity
timeFrame: Through study completion
measure: PSA
timeFrame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
measure: IPSS
timeFrame: Screening and 3, 6-9 and 12-15 months after radiotherapy
measure: Quality of Life Score
timeFrame: At the time of inclusion and 12-15 months after radiotherapy
measure: Decision Regret Score
timeFrame: At the time of inclusion and 12-15 months after radiotherapy
Other outcomes:
Locations:
city: Munich
country: Germany
facility: European Radiosurgery Center Munich
state: BA
city: Frankfurt
country: Germany
facility: Saphir Radiosurgery Center Frankfurt am Main
state: HE
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: HE
city: Kiel
country: Germany
facility: Saphir Radiosurgery Center Norther Germany
state: SH
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein
state: SH
city: Erfurt
country: Germany
facility: CyberKnife Centrum Mitteldeutschland
state: TH
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: David Krug, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.