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

August 9, 2017 updated by: University of Erlangen-Nürnberg Medical School
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • University Hospital
        • Contact:
        • Principal Investigator:
          • Vratislav Strnad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focal Brachytherapy
HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy
Radiation: HDR-Brachytherapy
HDR-Brachytherapy 2x 13,5 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity and frequency of adverse events
Time Frame: 6 weeks after therapy
6 weeks after therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor regression
Time Frame: 6 weeks up to 10 years after therapy
6 weeks up to 10 years after therapy
Rate of recurrences measured by PSA
Time Frame: 10 years after therapy
10 years after therapy
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
10 years after therapy
Correlation of microRNA141 and -375 with outcome
Time Frame: 10 years after therapy
10 years after therapy
Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ
Time Frame: 6 weeks after therapy
6 weeks after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Study Chair: Vratislav Strnad, MD, University Hospital Erlangen, Dept. of Radiooncology
  • Study Chair: Bastian Keck, MD, University Hospital Erlangen, Dept. of Urology
  • Study Chair: Alexander Cavallaro, MD, University Hospital Erlangen, Dept. of Radiology
  • Study Chair: Arndt Hartmann, MD, University Hospital Erlangen, Dept. of Pathology
  • Study Chair: Michael Lotter, Dipl.-Phys., University Hospital Erlangen, Dept. of Radiooncology
  • Study Chair: Annedore Strnad, MD, MHBA, University Hospital Erlangen, Dept. of Radiooncology
  • Study Chair: Peter Goebell, MD, University Hospital Erlangen, Dept. of Urology
  • Study Chair: Wolfgang Uter, MD, University Erlangen; Dept. of Biometrics and Epidemiology
  • Study Chair: Michael Uder, MD, University Hospital Erlangen, Dept. of Radiology
  • Study Chair: Bernd Wullich, MD, University Hospital Erlangen, Dept. of Urology
  • Study Chair: Rainer Fietkau, MD, University Hospital Erlangen, Dept. of Radiooncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOKAL-BT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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