Prostate CancerPhase 2FOKAL-BTNCT02391051
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
A Phase 2 study testing HDR-Brachytherapy in people with Prostate Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HDR-Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Prostate volume < 60 m^3
- No distant metastasis
- Life expectancy > 10 years
- Informed consent
Who cannot join
- Tumor stage ≥ T2b
- Known metastasis: N+ and/or M1
- General anesthesia or peridural anesthesia is not possible
- Coagulation disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Erlangen, 91054
Vratislab Strnad, MD, ++49-9131-85 ext. 33968, st-studiensekretariat@uk-erlangen.de
Vratislav Strnad, MD
About this study
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
Read the detailed description
Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.
- Conditions
- Prostate Cancer
- Being tested
- HDR-Brachytherapy
- Keywords
- prostate cancer, focal brachytherapy, PSA, Biological marker
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR-BrachytherapyRadiation
HDR-Brachytherapy 2x 13,5 Gy
| Study group | Role | What they receive |
|---|---|---|
| Focal Brachytherapy | Experimental | HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy Receives: Radiation: HDR-Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity and frequency of adverse events
Measured: 6 weeks after therapy
Secondary outcomes (5)
Tumor regression
Measured: 6 weeks up to 10 years after therapy
Rate of recurrences measured by PSA
Measured: 10 years after therapy
Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival
Measured: 10 years after therapy
Correlation of microRNA141 and -375 with outcome
Measured: 10 years after therapy
Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ
Measured: 6 weeks after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vratislav Strnad, MD, Study chair, University Hospital Erlangen, Dept. of RadiooncologyBastian Keck, MD, Study chair, University Hospital Erlangen, Dept. of UrologyAlexander Cavallaro, MD, Study chair, University Hospital Erlangen, Dept. of RadiologyArndt Hartmann, MD, Study chair, University Hospital Erlangen, Dept. of PathologyMichael Lotter, Dipl.-Phys., Study chair, University Hospital Erlangen, Dept. of RadiooncologyAnnedore Strnad, MD, MHBA, Study chair, University Hospital Erlangen, Dept. of RadiooncologyPeter Goebell, MD, Study chair, University Hospital Erlangen, Dept. of UrologyWolfgang Uter, MD, Study chair, University Erlangen; Dept. of Biometrics and Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391051
- Sponsor's protocol ID
- FOKAL-BT
- Acronym
- FOKAL-BT
- Status last verified
- Aug 2017
- First submitted
- 1 Jul 2014
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
- ClinicalTrials.gov ID
- NCT02391051
- Acronym / sponsor ID
- FOKAL-BT / FOKAL-BT
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, focal brachytherapy, PSA, Biological marker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal Brachytherapy | Experimental | Radiation: HDR-BrachytherapyHDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- Tumor stage ≥ T2b
- Known metastasis: N+ and/or M1
- General anesthesia or peridural anesthesia is not possible
- Coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDR-BrachytherapyHDR-Brachytherapy 2x 13,5 Gy | Radiation | Focal Brachytherapy |
Primary outcome
Intensity and frequency of adverse events
Time frame: 6 weeks after therapy
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vratislav Strnad, MD study chair
University Hospital Erlangen, Dept. of Radiooncology
Bastian Keck, MD study chair
University Hospital Erlangen, Dept. of Urology
Alexander Cavallaro, MD study chair
University Hospital Erlangen, Dept. of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDR-Brachytherapy in people with Prostate Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity and frequency of adverse events (time frame: 6 weeks after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.