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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02391051
Other study ID # FOKAL-BT
Secondary ID
Status Recruiting
Phase Phase 2
First received July 1, 2014
Last updated August 9, 2017
Start date October 2014
Est. completion date December 2029

Study information

Verified date August 2017
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2029
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Radiation:
HDR-Brachytherapy
HDR-Brachytherapy 2x 13,5 Gy

Locations

Country Name City State
Germany University Hospital Erlangen

Sponsors (1)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity and frequency of adverse events 6 weeks after therapy
Secondary Tumor regression 6 weeks up to 10 years after therapy
Secondary Rate of recurrences measured by PSA 10 years after therapy
Secondary Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival 10 years after therapy
Secondary Correlation of microRNA141 and -375 with outcome 10 years after therapy
Secondary Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ 6 weeks after therapy
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