Clinical trial NCT03795337: Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
Official title: Hypofractionated Radiosurgery for Localised Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Hypofractionation
Prostate Cancer
Radiotherapy
long-term toxicity
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Luebeck
name: Saphir Radiosurgery Center Northern Germany
First posted: 2019-01-07
Enrollment: 475
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 under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.

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 eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).

Eligibility criteria: Inclusion Criteria:

* non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 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:

* Age ≤ 60 years
* 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: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
Secondary outcomes:
measure: Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
timeFrame: 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
measure: Prostate Specific Antigen (PSA)
timeFrame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
measure: International Prostate Symptom Score (IPSS)
timeFrame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
measure: EORTC Quality of Life Questionnaire (QLQ) C30
timeFrame: At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)
city: Cologne
country: Germany
facility: University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy
city: Erfurt
country: Germany
facility: CyberKnife Centrum Mitteldeutschland
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: Kiel
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
affiliation: European CyberKnife Center Munich
name: Alexander Muacevic, Prof.
role: PRINCIPAL_INVESTIGATOR
References: