Clinical trial NCT02391051: Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
Official title: Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
focal brachytherapy
PSA
Biological marker
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intensity and frequency of adverse events
timeFrame: 6 weeks after therapy
Secondary outcomes:
measure: Tumor regression
timeFrame: 6 weeks up to 10 years after therapy
measure: Rate of recurrences measured by PSA
timeFrame: 10 years after therapy
measure: Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival
timeFrame: 10 years after therapy
measure: Correlation of microRNA141 and -375 with outcome
timeFrame: 10 years after therapy
measure: Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ
timeFrame: 6 weeks after therapy
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital
Study officials:
affiliation: University Hospital Erlangen, Dept. of Radiooncology
name: Vratislav Strnad, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Urology
name: Bastian Keck, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Radiology
name: Alexander Cavallaro, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Pathology
name: Arndt Hartmann, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Radiooncology
name: Michael Lotter, Dipl.-Phys.
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Radiooncology
name: Annedore Strnad, MD, MHBA
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Urology
name: Peter Goebell, MD
role: STUDY_CHAIR
affiliation: University Erlangen; Dept. of Biometrics and Epidemiology
name: Wolfgang Uter, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Radiology
name: Michael Uder, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Urology
name: Bernd Wullich, MD
role: STUDY_CHAIR
affiliation: University Hospital Erlangen, Dept. of Radiooncology
name: Rainer Fietkau, MD
role: STUDY_CHAIR
References: