HistScanning- Based PDR Brachytherapy in Prostate Cancer... | NCT01409876

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

NCT01409876

Sponsor

University Hospital Erlangen

Status

Unknown status

Last Update Posted

Aug 4, 2011Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

brachytherapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2014Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Aug 3, 2011

First Submission Date that Met QC Criteria

Aug 3, 2011

First Posted Date

Aug 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2011

Last Update Posted Date

Aug 4, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital ErlangenOTHER

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brachytherapy	Experimental		Radiation: brachytherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
brachytherapy	Radiation	interstitial image- guided PDR/HDR brachytherapy	Brachytherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy		5 years

Secondary Outcomes

Measure	Description	Time Frame
assessing tumor response and side effects		5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sebastian Lettmaier, MD	Contact	09131 85 44216		sebastianlettmaier@uk-erlangen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiation Therapy University Hospital		Erlangen		91054	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35396138	Derived	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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics