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OpenTrials
Completed

NCT Number: NCT02635256

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%.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Saphir Radiosurgery Center Frankfurt am Main, Frankfurt am Main, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated Radiosurgery

Radiation

Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife

Primary outcomes

  1. Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score

    Time frame: 12-15 months after radiotherapy

Secondary outcomes

  1. Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.

    Time frame: through study completion

  2. Prostate Specific Antigen (PSA)

    Time frame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy

  3. International Prostate Symptom Score (IPSS)

    Time frame: Screening and 3, 6-9 and 12-15 months after radiotherapy

  4. EORTC Quality of Life Questionnaire (QLQ) C30

    Time frame: At the time of inclusion and 12-15 months after radiotherapy

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • Saphir Radiosurgery Center Northern Germany
  • University of Luebeck

Registry information

Acronym: HYPOSTAT

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Dec 18, 2015
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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