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HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
brachytherapy
Sponsored by
University Hospital Erlangen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring histoscanning, brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion criteria:

  • All patients who do not meet the inclusion criteria
  • T4 carcinomas
  • Proven metastases N+ and/or M1
  • Epidural or general anaesthesia not possible
  • Pathological clotting parameters

Sites / Locations

  • Department of Radiation Therapy University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brachytherapy

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy

Secondary Outcome Measures

assessing tumor response and side effects

Full Information

First Posted
August 3, 2011
Last Updated
August 3, 2011
Sponsor
University Hospital Erlangen
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1. Study Identification

Unique Protocol Identification Number
NCT01409876
Brief Title
HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy
Official Title
HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Erlangen

4. Oversight

5. Study Description

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 Evaluating tumor response using HistoScanning Evaluating locoregional recurrence rates by measuring PSA Analysis of the correlation between tumor response as determined by HistoScanning and PSA response Evaluating the safety dose-painting image- guided interstitial brachytherapy by recording serious adverse events
Detailed Description
Rationale: The study is designed as a prospective monocentric phase II trial. The choice of the therapeutic concept is governed by the risk group that the patient falls into. Risk groups are defined according to the classification by D' Amico. The following concepts will be used: HDR brachytherapy: 19,0- 38 Gy / 2-4 fractions (2-4 x 9,5 Gy) PDR brachytherapy: 35-70 Gy / 50 --100 pulses(1 puls/h, 24 h/d) Dose painting the timorous areas as seen in HistoScanning as covered with a dose Dref2>130-150% External beam radiotherapy will be used in addition to brachytherapy for intermediate and high risk patients. The following concepts will be used 50,40 Gy / 28 fractions at 1.8 Gy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
histoscanning, brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brachytherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Description
interstitial image- guided PDR/HDR brachytherapy
Primary Outcome Measure Information:
Title
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
Time Frame
5 years
Secondary Outcome Measure Information:
Title
assessing tumor response and side effects
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion criteria: All patients who do not meet the inclusion criteria T4 carcinomas Proven metastases N+ and/or M1 Epidural or general anaesthesia not possible Pathological clotting parameters
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Lettmaier, MD
Phone
09131 85 44216
Email
sebastianlettmaier@uk-erlangen.de
Facility Information:
Facility Name
Department of Radiation Therapy University Hospital
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vratislav Strnad, MD, Prof
Phone
+49 9131 85 33419
Email
vratislav.strnad@uk-erlangen.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
35396138
Citation
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.
Results Reference
derived

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HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy

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