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NCT06914544 | NOT YET RECRUITING | Prostate Cancer

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Sponsor:

University Hospital Schleswig-Holstein

Brief Summary:

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.

Condition or disease

Prostate Cancer

Intervention/treatment

Hypofractionated Radiosurgery

Phase

NA

Detailed 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 175 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2029-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

Location Details

NCT06914544

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany, BA

European Radiosurgery Center Munich

Munich, BA, Germany, 81377

Not yet recruiting

Germany, HE

Saphir Radiosurgery Center Frankfurt am Main

Frankfurt, HE, Germany, 60528

Not yet recruiting

Germany, HE

University Hospital Frankfurt

Frankfurt, HE, Germany, 60528

Not yet recruiting

Germany, SH

Saphir Radiosurgery Center Norther Germany

As, SH, Germany, 24105

Not yet recruiting

Germany, SH

University Medical Center Schleswig-Holstein

As, SH, Germany, 24105

Not yet recruiting

Germany, TH

Cyberknife Centrum Central Germany

Erfurt, TH, Germany, 99089