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

Prostate Cancer Clinical Trial

— FOKAL-BT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02391051
• Other study ID #: FOKAL-BT
• 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
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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