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

NCT02391051 | Recruiting Phase 2

• 1 other identifier: FOKAL-BT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

prostate cancer; focal brachytherapy; PSA; Biological marker

Outcome Measures

Primary Outcomes (1)

• Intensity and frequency of adverse events

  6 weeks after therapy

Secondary Outcomes (5)

• Tumor regression

  6 weeks up to 10 years after therapy

• Rate of recurrences measured by PSA

  10 years after therapy

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

  10 years after therapy

• Correlation of microRNA141 and -375 with outcome

  10 years after therapy

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

  6 weeks after therapy

Study Arms (1)

Focal Brachytherapy

EXPERIMENTAL

HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy

Radiation: HDR-Brachytherapy

Interventions

HDR-Brachytherapy RADIATION

HDR-Brachytherapy 2x 13,5 Gy

Focal Brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: March 18, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

DE (1)