Hypofractionated Radiosurgery for Localised Prostate Cancer

Hypofractionated Radiosurgery for Localised Prostate Cancer

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%.

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).

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