Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

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 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).

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