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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

HDR-Brachytherapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, focal brachytherapy, PSA, Biological marker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal Brachytherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Intensity and frequency of adverse events

Secondary Outcome Measures

Tumor regression

Rate of recurrences measured by PSA

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

Correlation of microRNA141 and -375 with outcome

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

Full Information

NCT ID

NCT02391051

First Posted

July 1, 2014

Last Updated

August 9, 2017

Sponsor

University of Erlangen-Nürnberg Medical School

1. Study Identification

Unique Protocol Identification Number

NCT02391051

Brief Title

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

Acronym

FOKAL-BT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Recruiting

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, focal brachytherapy, PSA, Biological marker

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Focal Brachytherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

HDR-Brachytherapy

Intervention Description

HDR-Brachytherapy 2x 13,5 Gy

Primary Outcome Measure Information:

Title

Intensity and frequency of adverse events

Time Frame

6 weeks after therapy

Secondary Outcome Measure Information:

Title

Tumor regression

Time Frame

6 weeks up to 10 years after therapy

Title

Rate of recurrences measured by PSA

Time Frame

10 years after therapy

Title

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

Title

Correlation of microRNA141 and -375 with outcome

Time Frame

10 years after therapy

Title

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

Time Frame

6 weeks after therapy

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vratislav Strnad, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Radiooncology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bastian Keck, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Urology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Alexander Cavallaro, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Radiology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Arndt Hartmann, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Pathology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michael Lotter, Dipl.-Phys.

Organizational Affiliation

University Hospital Erlangen, Dept. of Radiooncology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Annedore Strnad, MD, MHBA

Organizational Affiliation

University Hospital Erlangen, Dept. of Radiooncology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Peter Goebell, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Urology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wolfgang Uter, MD

Organizational Affiliation

University Erlangen; Dept. of Biometrics and Epidemiology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michael Uder, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Radiology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bernd Wullich, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Urology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Rainer Fietkau, MD

Organizational Affiliation

University Hospital Erlangen, Dept. of Radiooncology

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vratislab Strnad, MD

Phone

++49-9131-85

Ext

33968

st-studiensekretariat@uk-erlangen.de

First Name & Middle Initial & Last Name & Degree

Vratislav Strnad, MD

12. IPD Sharing Statement

Learn more about this trial

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

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