Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial

  • STATUS
    Recruiting
  • End date
    Dec 21, 2029
  • participants needed
    50
  • sponsor
    University of Erlangen-Nürnberg Medical School
Updated on 21 January 2021
metastasis
brachytherapy

Summary

This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.

Description

Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Prostatic disorder, Prostate Disorders, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment HDR-Brachytherapy
Clinical Study IdentifierNCT02391051
SponsorUniversity of Erlangen-Nürnberg Medical School
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 18
Histologically confirmed prostate cancer
Gleason Score of index lesion 6 (3+3)
Tumor stage: cT1-2a cN0 cM0
Unilateral affection; index lesion 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment
PSA 10/ng/ml
Prostate volume < 60 m^3
No distant metastasis
Life expectancy > 10 years
Informed consent

Exclusion Criteria

Tumor stage T2b
Known metastasis: N+ and/or M1
General anesthesia or peridural anesthesia is not possible
Coagulation disorder
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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