Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

University Hospital Schleswig-Holstein175 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Prostate Cancer

Interventions

Hypofractionated RadiosurgeryRADIATION

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Saphir Radiosurgery Center Frankfurt am Main

Frankfurt am Main, Hesse, Germany

RECRUITING

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

SUSPENDED

European Radiosurgery Center Munich

Munich, Hesse, Germany

Outcomes

Primary Outcomes

GU and GI Toxicity

Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score

Time frame: 12-15 months after radiotherapy

Secondary Outcomes

Acute toxicity

Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports

Time frame: Through study completion

PSA

Prostate Specific Antigen (PSA)

Time frame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy

IPSS

International Prostate Symptom Score (IPSS) on a scale 0-35 with lower being better

Time frame: Screening and 3, 6-9 and 12-15 months after radiotherapy

Quality of Life Score

EORTC Quality of Life Questionnaire (QLQ) C30 on a scale 0-100 with higher being better

Time frame: At the time of inclusion and 12-15 months after radiotherapy

Decision Regret Score

Decision Regret Score on a scale 0-100 with lower being lower regret

Time frame: At the time of inclusion and 12-15 months after radiotherapy

Central Contacts

Oliver Blanck, PhD

CONTACT

+4943150026666 oliver.blanck@uksh.de

Frauke Walther-Clausnizer

CONTACT

+4943150026581 Frauke.Walther-Clausnizer@uksh.de

Data from ClinicalTrials.gov

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