Status:

ACTIVE_NOT_RECRUITING

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Lead Sponsor:

University Hospital Heidelberg

Collaborating Sponsors:

Ludwig-Maximilians - University of Munich

University Hospital, Zürich

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

NA

Brief Summary

As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in th...

Eligibility Criteria

Inclusion

  • Histologically confirmed prostate carcinoma with tissue classification according to Gleason score and PSA
  • low- or intermediate-risk carcinoma according to d'Amico criteria or early high-risk Carcinoma (cT3a and / or GS ≤ 8 and / or PSA ≤ 20ng / ml)
  • IPSS (International Prostate Symptom Score) max. 12
  • Prostate volume \<80cm³
  • Karnofsky index ≥ 70%
  • Age ≥ 18 years
  • Patient information provided and written consent
  • Ability of the patient to give consent

Exclusion

  • Previous radiotherapy in the pelvis
  • Previous local therapy of the prostate
  • lymphogenic metastasis
  • Stage IV (distant metastases)
  • Contraindication to MRI
  • Simultaneous participation in another clinical study which could influence results of either of the respective study

Key Trial Info

Start Date :

March 25 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 25 2028

Estimated Enrollment :

68 Patients enrolled

Trial Details

Trial ID

NCT04845503

Start Date

March 25 2021

End Date

March 25 2028

Last Update

February 20 2025

Active Locations (1)

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1

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany, 69120