Prostate Cancer
Conditions
Keywords
prostate cancer, focal brachytherapy, PSA, Biological marker
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.
Interventions
RADIATIONHDR-Brachytherapy
HDR-Brachytherapy 2x 13,5 Gy
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity and frequency of adverse events | 6 weeks after therapy |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival | 10 years after therapy |
| Tumor regression | 6 weeks up to 10 years after therapy |
| Rate of recurrences measured by PSA | 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 |
Countries
Germany
Outcome results
None listed