Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

University Hospital Schleswig-Holstein475 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

475

Conditions

Prostate Cancer

Interventions

Hypofractionated RadiosurgeryRADIATION

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

Eligibility

Sex: MALEMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (8)

Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)

Berlin, Germany

University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy

Cologne, Germany

CyberKnife Centrum Mitteldeutschland

Erfurt, Germany

Outcomes

Primary Outcomes

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

Time frame: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy

Secondary Outcomes

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

Time frame: 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy

Prostate Specific Antigen (PSA)

Time frame: 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

International Prostate Symptom Score (IPSS)

Time frame: 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

EORTC Quality of Life Questionnaire (QLQ) C30

Time frame: At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy

Data from ClinicalTrials.gov

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