Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Hypofractionated Radiosurgery for Localised Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypofractionated Radiosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated Radiosurgery<br>5 fractions with 7 Gy, total dose 35 Gy | Radiation: Hypofractionated Radiosurgery<br>* Image-guided stereotactic Linac based RT preferable with dedicated radiosurgery system such as CyberKnife<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score |  | 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. |  | 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy | 
| Prostate Specific Antigen (PSA) |  | 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) |  | 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 |  | At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypofractionation, Prostate Cancer, Radiotherapy, long-term toxicity