HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy
HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
This is a phase II trial looking at the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy in non- metastatic prostate cancer Endpoints: Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy Secondary endpoints
- 1.Evaluating tumor response using HistoScanning
- 2.Evaluating locoregional recurrence rates by measuring PSA
- 3.Analysis of the correlation between tumor response as determined by HistoScanning and PSA response
- 4.Evaluating the safety dose-painting image- guided interstitial brachytherapy by recording serious adverse events
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Sep 2011
Typical duration for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedAugust 4, 2011
March 1, 2011
3 years
August 3, 2011
August 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
5 years
Secondary Outcomes (1)
assessing tumor response and side effects
5 years
Study Arms (1)
Brachytherapy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically proven prostate cancer
- All cT1-3 carcinomas independent of grading and PSA value
- Prostate volume\< 70cc
- No distant metastases
- Karnofsky \> 60
- Written informed consent from the patient regarding study participation
You may not qualify if:
- T4 carcinomas
- Proven metastases N+ and/or M1
- Epidural or general anaesthesia not possible
- Pathological clotting parameters
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiation Therapy University Hospital
Erlangen, 91054, Germany
Related Publications (1)
Strnad V, Lotter M, Kreppner S, Fietkau R. Brachytherapy focal dose escalation using ultrasound based tissue characterization by patients with non-metastatic prostate cancer: Five-year results from single-center phase 2 trial. Brachytherapy. 2022 Jul-Aug;21(4):415-423. doi: 10.1016/j.brachy.2022.02.003. Epub 2022 Apr 6.
PMID: 35396138DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 3, 2011
First Posted
August 4, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2016
Last Updated
August 4, 2011
Record last verified: 2011-03