Hypofractionated Radiosurgery for Localised Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University Hospital Schleswig-Holstein
- Enrollment
- 85
- Locations
- 5
- Primary Endpoint
- Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.
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 four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).
Investigators
Juergen Dunst, Prof.
Prof. Dr. med. Juergen Dunst
University Hospital Schleswig-Holstein
Eligibility Criteria
Inclusion Criteria
- •Localised, histopathologically confirmed Prostate Cancer (cT1-3 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
- •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
Outcomes
Primary Outcomes
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Time Frame: 12-15 months after radiotherapy
Secondary Outcomes
- Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.(through study completion)
- International Prostate Symptom Score (IPSS)(Screening and 3, 6-9 and 12-15 months after radiotherapy)
- Prostate Specific Antigen (PSA)(At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy)
- EORTC Quality of Life Questionnaire (QLQ) C30(At the time of inclusion and 12-15 months after radiotherapy)