Prostate Cancer Clinical Trial
— FOKAL-BTOfficial title:
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
Verified date | August 2017 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital | Erlangen |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
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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