Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

University Hospital Schleswig-Holstein (UKSH)

Status: Begins enrollment in 2 months

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06914544

DRKS00036292 (Registry Identifier)

ARO-2024-3

Details and patient eligibility

About

Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.

Full description

Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.

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).

Enrollment: 175 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
• Gleason-grade ≤7, ISUP Grade Group 1-3
• Guideline-based staging
• Age ≥ 18 years
• PSA < 20 ng/ml
• Volume of the prostate < 80 cm³
• IPSS-Score ≤ 12
• Written informed consent

Exclusion criteria

• History of prior pelvic radiotherapy
• Previous transurethral resection, laser enucleation or prostate ablation
• Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
• 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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175 participants in 1 patient group

Hypofractionated Radiosurgery

Experimental group

Description:

3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 Gy

Treatment:

Radiation: Hypofractionated Radiosurgery