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NCT Number: NCT02391051

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

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

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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

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital

Erlangen, 91054, Germany

Location status: Recruiting

Location contact

Vratislab Strnad, MD

CONTACT

[email protected]

++49-9131-85 ext. 33968

Vratislav Strnad, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

HDR-Brachytherapy

Radiation

HDR-Brachytherapy 2x 13,5 Gy

Primary outcomes

  1. Intensity and frequency of adverse events

    Time frame: 6 weeks after therapy

Secondary outcomes

  1. Tumor regression

    Time frame: 6 weeks up to 10 years after therapy

  2. Rate of recurrences measured by PSA

    Time frame: 10 years after therapy

  3. Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival

    Time frame: 10 years after therapy

  4. Correlation of microRNA141 and -375 with outcome

    Time frame: 10 years after therapy

  5. Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ

    Time frame: 6 weeks after therapy

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Acronym: FOKAL-BT

Important dates

Study start
2014
Primary completion
2019
Study completion
2029
First posted
Mar 18, 2015
Registry last updated
Aug 11, 2017

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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