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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01409876

Enrollment

100

Registered

2011-08-04

Start date

2011-09-30

Completion date

2016-09-30

Last updated

2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

histoscanning, brachytherapy

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

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

Interventions

RADIATIONbrachytherapy

interstitial image- guided PDR/HDR brachytherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
assessing tumor response and side effects	5 years

Countries

Germany

Contacts

Primary ContactSebastian Lettmaier, MD

sebastianlettmaier@uk-erlangen.de09131 85 44216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026