Recruiting NCT02391051
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HDR-Brachytherapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Radiation HDR-Brachytherapy
HDR-Brachytherapy 2x 13,5 Gy
Primary outcome measures
- Intensity and frequency of adverse events [Time frame: 6 weeks after therapy]
Secondary outcome measures (5)
- Tumor regression [Time frame: 6 weeks up to 10 years after therapy]
- Rate of recurrences measured by PSA [Time frame: 10 years after therapy]
- Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival [Time frame: 10 years after therapy]
- Correlation of microRNA141 and -375 with outcome [Time frame: 10 years after therapy]
- Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ [Time frame: 6 weeks after therapy]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Hospital — Erlangen
Identifiers
NCT: NCT02391051 · FOKAL-BT