Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

University Hospital Schleswig-Holstein (UKSH)

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03795337

ZKS-121-08

ARO-2018-4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).

Enrollment: 475 patients

Sex: Male

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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475 participants in 1 patient group

Hypofractionated Radiosurgery

Experimental group

Description:

5 fractions with 7 Gy, total dose 35 Gy

Treatment:

Radiation: Hypofractionated Radiosurgery