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

University Hospital Erlangen

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01409876

HistoBrachy1

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Brachytherapy

Experimental group

Treatment:

Radiation: brachytherapy