Clinical trial NCT01409876: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: histoscanning
brachytherapy
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
timeFrame: 5 years
Secondary outcomes:
measure: assessing tumor response and side effects
timeFrame: 5 years
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Radiation Therapy University Hospital
Study officials:
References:
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.