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

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: HDR-Brachytherapy

• Registration Number: NCT02391051
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Study Timeline

• Study First Submitted: 2014-07-01
• Study Start: 2014-10
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-18
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11
• Primary Completion: 2019-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intensity and frequency of adverse events	6 weeks after therapy

Secondary Outcome Measures

Name	Time	Method
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
Tumor regression	6 weeks up to 10 years after therapy
Rate of recurrences measured by PSA	10 years after therapy

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Erlangen, Germany