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Biomedical subjects

Roland Felix

Publications and source records attributed to Roland Felix.

At least 37 records · Page 2Linked to original sources
PubMed2006

Intraluminal brachytherapy of de novo TIPS: a prospective randomized double-blind study.

OBJECTIVE: The aim of this prospective double-blind and randomized study was to assess whether intraluminal brachytherapy of de novo transjugular intrahepatic portosystemic shunts (TIPS) can prevent significant shunt stenosis. SUBJECTS AND METHODS: Forty patients with portal hypertension due to liver cirrhosis were enrolled. In the irradiation group of 20 patients, the gamma radiation source, iridium-192, was introduced into the shunt within a special balloon catheter that allows the radionuclide to be centered within the shunt. A dose of 14 Gy in the shunt wall at a depth of 2 mm should be achieved. In the control group of 20 patients, a dummy source was used. Doppler sonography was performed immediately, 1 day, 1 week, 4 weeks, and 3 months after TIPS placement and then at an interval of 3 months during the first year. The primary end point of the study was the percentage of patients who developed significant shunt stenosis, defined as a reduction of maximum flow velocity below 50 cm/sec in the proximal part of the shunt 1 cm from the entry of the stent into the punctured portal vein branch. Fisher's exact test was used. RESULTS: The TIPS procedure was technically successful in all patients. Seventeen patients in the irradiation group and 15 patients in the control group were followed up. Five patients (29.4%) in the irradiation group and 10 (66.7%) in the control group developed significant shunt stenosis during the first year after TIPS placement (p = 0.0392). The time until such stenosis occurred did not differ significantly between the two groups. CONCLUSION: Our results suggest that brachytherapy can be useful in reducing the incidence of TIPS stenosis. A larger study with histopathologic analysis may be needed to confirm these findings.

Adult↗
PubMed2006

Intrinsically radiopaque iodine-containing polyvinyl alcohol as a liquid embolic agent: evaluation in experimental wide-necked aneurysms.

OBJECT: To evaluate iodine-containing polyvinyl alcohol (I-PVA) as a precipitating liquid embolic agent, implant characteristics--including radiopacity, setting behavior, and biocompatibility--were studied in an aneurysm model in swine. METHODS: Twelve broad-based carotid artery (CA) sidewall aneurysms were surgically constructed in six pigs. Iodine-containing polyvinyl alcohol dissolved in dimethyl sulfoxide (DMSO) was injected during temporary balloon occlusion bridging the aneurysm neck. Control angiography as well as multidetector row computerized tomography (CT) angiography was performed after 4 weeks. Harvested aneurysms were investigated histopathologically and by 3-tesla high-field magnetic resonance (MR) imaging. The mean degree of aneurysm occlusion achieved was 96%. In two aneurysms a minimal protrusion of I-PVA into the CA lumen was observed. During one embolization, leakage of the liquid embolic agent due to DMSO-induced damage of the microcatheter resulted in CA occlusion. Aneurysms embolized with I-PVA could be discriminated clearly from the parent artery on CT angiograms because there was no beam-hardening artifact. High-field MR imaging allowed a detailed depiction of the liquid embolic distribution within the aneurysm. Histologically, a mild to moderate inflammatory response was found in successfully embolized aneurysms, and the polymer mass was frequently covered by a membrane of fibroblasts and endothelial cells. CONCLUSIONS: Iodine-containing polyvinyl alcohol is a ready-to-use liquid embolic agent clearly visible under fluoroscopy; additives are not required. The setting behavior allows for controlled delivery in aneurysm cavities. Histological studies performed 4 weeks after embolization revealed no sign of toxic tissue response to the liquid embolic agent. Overall, I-PVA exhibits interesting implant characteristics in that radiopaque admixtures are not necessary, thus allowing for artifact-free evaluation of treated aneurysms by using CT and MR angiography.

Aneurysm↗
PubMed2005

The effect of thermotherapy using magnetic nanoparticles on rat malignant glioma.

Thermotherapy using magnetic nanoparticles is a new technique for interstitial hyperthermia and thermoablation based on magnetic field-induced excitation of biocompatible superparamagnetic nanoparticles. To evaluate the potential of this technique for minimally invasive treatment, we carried out a systematic analysis of its effects on experimental glioblastoma multiforme in a rat tumor model. Tumors were induced by implantation of RG-2-cells into the brains of 120 male Fisher rats. Animals were randomly allocated to 10 groups of 12 rats each, including controls. Animals received two thermotherapy treatments following a single intratumoral injection of two different magnetic fluids (dextran- or aminosilane-coated iron-oxide nanoparticles). Treatment was carried out on days four and six after tumor induction using an alternating magnetic field applicator system operating at a frequency of 100 kHz and variable field strength of 0-18 kA/m. The effectiveness of treatment was determined by the survival time of the animals and histopathological examinations of the brain and the tumor.Thermotherapy with aminosilane-coated nanoparticles led up to 4.5-fold prolongation of survival over controls, while the dextran-coated particles did not indicate any advantage. Intratumoral deposition of the aminosilane-coated particles was found to be stable, allowing for serial thermotherapy treatments without repeated injection. Histological and immunohistochemical examinations after treatment revealed large necrotic areas close to particle deposits, a decreased proliferation rate and a reactive astrogliosis adjacent to the tumor.Thus, localized interstitial thermotherapy with magnetic nanoparticles has an antitumoral effect on malignant brain tumors. This method is suitable for clinical use and may be a novel strategy for treating malignant glioma, which cannot be treated successfully today. The optimal treatment schedules and potential combinations with other therapies need to be defined in further studies.

Animals↗
PubMed2005

Value of axial and coronal maximum intensity projection (MIP) images in the detection of pulmonary nodules by multislice spiral CT: comparison with axial 1-mm and 5-mm slices.

The purpose of this study was to investigate the diagnostic accuracy of non-overlapping 10-mm axial and coronal maximum intensity projections (MIP) in comparison with standard axial 1-mm and 5-mm slices in the detection of pulmonary nodules. Sixty patients with suspected nodules who underwent multislice spiral CT of the chest were evaluated. Axial 1-mm and 5-mm slices as well as non-overlapping 10-mm axial/coronal MIPs were interpreted independently by three blinded radiologists. After initial review, a retrospective consensus session was performed for agreement on final nodule counts using the axial 1-mm slices as gold standard. Small nodules of less than 5 mm in size were most accurately detected by the axial MIPs. Receiver operating characteristic (ROC) analysis of these small nodules showed that 5-mm slices were not capable of a statistically significant differentiation of nodules from other focal lesions in two observers (p=0.034 and p=0.012, respectively) whereas 1-mm slices and coronal/axial MIPs did allow a statistically significant differentiation in all observers (p<0.001). Nodules larger than 5 mm were equally well depicted with all modalities. Non-overlapping 10-mm axial MIPs improve the accuracy in the detection of small pulmonary nodules.

Adolescent↗
PubMed2005

Follow-up of gastro-intestinal stromal tumours (GIST) during treatment with imatinib mesylate by abdominal MRI.

Typical MRI findings for gastro-intestinal stromal tumours (GIST) under treatment with imatinib were evaluated. MRI was performed in 45 patients (25 responders, 20 non-responders) with metastatic or locally advanced, unresectable GIST. Target lesions were selected and re-evaluated after 2, 4, and 6 months of therapy with imatinib. The target tumour response (TTR) was classified according to RECIST criteria. TTR, signal intensity in the centre and border of the lesion and the presence and the extension of a hypervascular rim were analysed. The mean diameter of the marker lesions decreased significantly (P<0.001) from 7.1+/-2.6 cm to 5.9+/-2.3 cm after 6 months. Accuracy of RECIST criteria was 51%, 69% and 73% on MRI 2, 4 and 6 months for response assessment. In addition, responders had higher signal-to-noise ratios on T2-w images after 2 months (P<0.05) and a decrease of vascularised areas in the lesion 4 and 6 months after treatment (each P<0.01), when compared with non-responders. Beyond the size measurement for response assessment, MRI provides additional information of tumour response using SI of T2-w images and quantification of vascularised areas of GIST manifestations.

Abdomen↗
PubMed2005

In vivo assessment of the tolerance dose of small liver volumes after single-fraction HDR irradiation.

PURPOSE: To prospectively assess a dose-response relationship for small volumes of liver parenchyma after single-fraction irradiation. METHODS AND MATERIALS: Twenty-five liver metastases were treated by computed tomography (CT)-guided interstitial brachytherapy. Magnetic resonance imaging was performed 1 day before and 3 days and 6, 12, and 24 weeks after therapy. MR sequences included T1-w gradient echo (GRE) enhanced by hepatocyte-targeted gadobenate dimeglumine. All MRI data sets were merged with 3D dosimetry data and evaluated by two radiologists. The reviewers indicated the border of hyperintensity on T2-w images (edema) or hypointensity on T1-w images (loss of hepatocyte function). Based on the total 3D data, a dose-volume histogram was calculated. We estimated the threshold dose for either edema or function loss as the D(90), i.e., the dose achieved in at least 90% of the pseudolesion volume. RESULTS: Between 3 days and 6 weeks, the extension of the edema increased significantly from the 12.9 Gy isosurface to 9.9 Gy (standard deviation [SD], 3.3 and 2.6). No significant change was detected between 6 and 12 weeks. After 24 weeks, the edematous tissue had shrunk significantly to 14.7 Gy (SD, 4.2). Three days postbrachytherapy, the D(90) for hepatocyte function loss reached the 14.9 Gy isosurface (SD, 3.9). At 6 weeks, the respective zone had increased significantly to 9.9 Gy (SD, 2.3). After 12 and 24 weeks, the dysfunction volume had decreased significantly to the 11.9 Gy and 15.2 Gy isosurface, respectively (SD, 3 and 4.1). CONCLUSIONS: The 95% interval from 7.6 to 12.2 Gy found as the minimal hepatocyte tolerance after 6 weeks accounts for the radiobiologic variations found in CT-guided brachytherapy, including heterogeneous dose rates by variable catheter arrays.

Adult↗
PubMed2005

Noninvasive magnetic resonance thermography of recurrent rectal carcinoma in a 1.5 Tesla hybrid system.

To implement noninvasive thermometry, we installed a hybrid system consisting of a radiofrequency multiantenna applicator (SIGMA-Eye) for deep hyperthermia (BSD-2000/3D) integrated into the gantry of a 1.5 Tesla magnetic resonance (MR) tomograph Symphony. This system can record MR data during radiofrequency heating and is suitable for application and evaluation of methods for MR thermography. In 15 patients with preirradiated pelvic rectal recurrences, we acquired phase data sets (25 slices) every 10 to 15 minutes over the treatment time (60-90 minutes) using gradient echo sequences (echo time = 20 ms), transformed the phase differences to MR temperatures, and fused the color-coded MR-temperature distributions with anatomic T1-weighted MR data sets. We could generate one complete series of MR data sets per patient with satisfactory quality for further analysis. In fat, muscle, water bolus, prostate, bladder, and tumor, we delineated regions of interest (ROI), used the fat ROI for drift correction by transforming these regions to a phase shift zero, and evaluated the MR-temperature frequency distributions. Mean MR temperatures (T(MR)), maximum T(MR), full width half maximum (FWHM), and other descriptors of tumors and normal tissues were noninvasively derived and their dependencies outlined. In 8 of 15 patients, direct temperature measurements in reference points were available. We correlated the tumor MR temperatures with direct measurements, clinical response, and tumor features (volume and location), and found reasonable trends and correlations. Therefore, the mean T(MR) of the tumor might be useful as a variable to evaluate the quality and effectivity of heat treatments, and consequently as optimization variable. Feasibility of noninvasive MR thermography for regional hyperthermia has been shown and should be further investigated.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2005

Combined SPECT/CT imaging using 123I-IMT in the detection of recurrent or persistent head and neck cancer.

The aim of the study was to assess the clinical value of combined SPECT/CT imaging using L: -3-[123I]iodine-alpha-methyl tyrosine (IMT) for the differential diagnosis of recurrences in patients pre-treated for head and neck cancer. Thirty-four consecutive patients with biopsy-proven carcinomas, who had previously been treated by surgery and/or radio/chemotherapy, were examined at our clinic by IMT-SPECT using a dual-head system with integrated low-dose CT. SPECT results were correlated with histopathology, clinical and CT/MRI follow-up data. In the follow-up after SPECT examination, the final diagnosis of recurrent tumour was established in 26 patients; the remaining eight patients were recurrence-free (follow-up >6 months). IMT-SPECT/CT correctly detected recurrent disease and/or neck lymph node metastases in 22 patients. In addition, distant metastases were displayed in two patients. The study was false-negative in four patients (sensitivity 85%). True-negative results were registered in seven patients, and false-positive in one patient. Image fusion with coregistered low-dose CT facilitates the localisation and interpretation of IMT-SPECT findings. IMT-SPECT using integrated low-dose CT is a promising non-invasive imaging tool for the detection of head and neck cancer recurrences and their differentiation from treatment-induced changes.

Adult↗
PubMed2005

Dose-escalated conformal radiotherapy of glioblastomas -- results of a retrospective comparison applying radiation doses of 60 and 70 Gy.

BACKGROUND: Dose escalated three-dimensional conformal radiotherapy with 70 Gy against glioblastomas was compared retrospectively with the standard scheme of 60 Gy using 2-D-planning. PATIENTS AND METHODS: In the period from 1994 to 1998, a series of 135 patients with glioblastomas was treated by surgery and postoperative radiotherapy. A conversion from 2-D into 3-D-planning was carried out in 4/1996. The prescribed total dose for the first 65 patients was 60 Gy (group 60). A boost up to 70 Gy was added for the remaining 70 patients (group 70). RESULTS: The median survival time was 8.0 months for group 60 and 8.3 months for group 70. A dependency on the applied dose range was found. The median survival time was 3 months for patients who received a radiation dose of 55 Gy or less, 8.6 months for doses between 56 and 65 Gy, and 9.6 months for patients with a dose between 66 and 75 Gy (p < 0.01). In a multivariate analysis only the performance status maintained significance (p = 0.02) as a prognostic factor, while the dose range reached borderline significance (p = 0.09). CONCLUSION: No statistically significant survival prolongation was reached despite a dose escalation to 70 Gy.

Brain Neoplasms↗
PubMed2005

Influence of high magnetic field strengths and parallel acquisition strategies on image quality in cardiac 2D CINE magnetic resonance imaging: comparison of 1.5 T vs. 3.0 T.

The aim of this paper is to examine signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR) and image quality of cardiac CINE imaging at 1.5 T and 3.0 T. Twenty volunteers underwent cardiac magnetic resonance imaging (MRI) examinations using a 1.5-T and a 3.0-T scanner. Three different sets of breath-held, electrocardiogram-gated (ECG) CINE imaging techniques were employed, including: (1) unaccelerated SSFP (steady state free precession), (2) accelerated SSFP imaging and (3) gradient-echo-based myocardial tagging. Two-dimensional CINE SSFP at 3.0 T revealed an SNR improvement of 103% and a CNR increase of 19% as compared to the results obtained at 1.5 T. The SNR reduction in accelerated 2D CINE SSFP imaging was larger at 1.5 T (37%) compared to 3.0 T (26%). The mean SNR and CNR increase at 3.0 T obtained for the tagging sequence was 88% and 187%, respectively. At 3.0 T, the duration of the saturation bands persisted throughout the entire cardiac cycle. For comparison, the saturation bands were significantly diminished at 1.5 T during end-diastole. For 2D CINE SSFP imaging, no significant difference in the left ventricular volumetry and in the overall image quality was obtained. For myocardial tagging, image quality was significantly improved at 3.0 T. The SNR reduction in accelerated SSFP imaging was overcompensated by the increase in the baseline SNR at 3.0 T and did not result in any image quality degradation. For cardiac tagging techniques, 3.0 T was highly beneficial, which holds the promise to improve its diagnostic value.

Adult↗
PubMed2005

Fusion imaging using a hybrid SPECT-CT camera improves port perfusion scintigraphy for control of hepatic arterial infusion of chemotherapy in colorectal cancer patients.

PURPOSE: Exclusive and homogeneous perfusion of the liver is considered essential for the efficacy of hepatic arterial infusion of chemotherapy (HAI). The aim of this study was to evaluate port perfusion scintigraphy in colorectal cancer patients using a hybrid SPECT-CT system for control of minimally invasive intra-arterial port systems within the scope of a phase II trial. METHODS: In 24 consecutive patients, the perfusion territories of intra-arterial hepatic port systems were assessed by port scintigraphy with( 99m)Tc-labelled macroaggregated albumin employing planar imaging, SPECT and SPECT-CT (acquired with a hybrid SPECT-CT camera). The results of blinded reading of the scintigraphic modalities concerning the intra- and extrahepatic perfusion pattern were compared with combined image analysis (angiography and contrast-enhanced dedicated CT) and patient history for validation. RESULTS: Extrahepatic perfusion was correctly seen in three patients, while suspected extrahepatic perfusion could be excluded in one. In 46 liver lobes, perfusion patterns were correctly visualised by SPECT-CT in 100% of cases (planar, 67%; SPECT, 86%). Assessing the perfusion pattern inside the liver on a segmental basis (segments, n=138), SPECT-CT revealed correct segmental assignment of tracer distribution in 100% and was significantly superior to SPECT alone (accuracy, 84%; p<0.001). The scintigraphic findings resulted in changes in therapeutic management in 8/24 patients (33%); in two of these the relevant findings were visualised only by SPECT-CT. CONCLUSION: In patients receiving HAI, port perfusion scintigraphy by fusion imaging with a hybrid SPECT-CT system provides important information for therapy optimisation and appears to be superior to SPECT alone.

Adult↗
PubMed2005

Detection of recurrent pancreatic cancer: comparison of FDG-PET with CT/MRI.

OBJECTIVE: To determine the value of fluorine-18-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) for the detection of recurrent pancreatic cancer in comparison to computed tomography (CT) and magnetic resonance imaging (MRI). METHODS: Thirty-one patients with suspected recurrence after surgery were included. Inclusion criteria were sudden weight loss, pain or increased CA 19-9 levels. FDG-PET was performed in all patients. After visual analysis, maximal standardized uptake values (SUVmax) were determined by placing regions of interest on the pancreas bed. Additionally, all patients underwent contrast-enhanced multidetector CT (n = 14) or MR (n = 17) imaging. Positive findings at FDG-PET or CT/MRI were compared to follow-up. RESULTS: All patients relapsed. Of 25 patients with local recurrences upon follow-up, initial imaging suggested relapse in 23 patients. Of these, FDG-PET detected 96% (22/23) and CT/MRI 39% (9/23). Local SUVmax ranged from 2.26 to 16.9 (mean, 6.06). Among 12 liver metastases, FDG-PET detected 42% (5/12). CT/MRI detected 92% (11/12) correctly. Moreover, 7/9 abdominal lesions were malignant upon follow-up of which FDG-PET detected 7/7 and CT/MR detected none. Additionally, FDG-PET detected extra-abdominal metastases in 2 patients. CONCLUSION: In patients suspected of pancreatic cancer relapse; FDG-PET reliably detected local recurrences, whereas CT/MRI was more sensitive for the detection of hepatic metastases. Furthermore, FDG-PET proved to be advantageous for the detection of nonlocoregional and extra-abdominal recurrences.

Adult↗
PubMed2005

Value of 123I-IMT SPECT for diagnosis of recurrent non-astrocytic intracranial tumours.

The value of single-photon emission tomography (SPECT) using iodine-123-alpha-methyl-tyrosine (IMT) for the diagnosis of recurrent or residual gliomas is well established. In the current study we investigated whether IMT-SPECT could also be useful in the follow-up of brain metastases and other intracranial tumours of non-astrocytic origin. The study included 22 patients with suspected recurrent intracranial tumours of non-astrocytic origin (12 brain metastases, one supratentorial primitive neuroendocrine tumour (PNET), one rhabdoid tumour, two clivus chordomas, three ependymomas, two pituitary tumours, one anaplastic meningioma) who had previously been treated by surgery and/or radio/chemotherapy. SPECT results were correlated with clinical and MRI follow-up data. The study was true positive in 13 patients, true negative in five, false positive in one and false negative in three patients. Notably, all false negative findings were <13 mm. The resulting sensitivity of the IMT-SPECT was 81%. We concluded that the IMT-SPECT is a promising complementary imaging tool for the detection of recurrences of non-astrocytic intracranial tumours and their distinguishing from treatment-induced changes. The limitation of the IMT-SPECT is its low sensitivity for the detection of small lesions.

Adolescent↗
PubMed2005

A practical approach to thermography in a hyperthermia/magnetic resonance hybrid system: validation in a heterogeneous phantom.

PURPOSE: This study investigates the feasibility and accuracy of noninvasive magnetic resonance (MR) monitoring for a system that includes a multiantenna applicator for part-body hyperthermia (SIGMA-Eye applicator, BSD-2000/3D) and a 1.5 Tesla MR tomograph (Siemens Magnetom Symphony). METHODS: A careful electrical decoupling enabled simultaneous operation of both systems, the hyperthermia system (100 MHz, up to 1600 W) and the MR tomograph (63.9 MHz). We used the phase data sets of a gradient echo sequence (long echo time TE = 20 ms) according to the proton frequency shift (PFS) method to determine MR temperature changes. Data postprocessing and visualization was conducted in the software platform AMIRA-HyperPlan. Heating was evaluated in an elliptical Lucite cylinder of 50 cm length filled with tissue-equivalent agarose and a skeleton made from low-dielectric material to simulate the heterogeneity of a real patient. Multiple catheters were included longitudinally for direct thermometry (using Bowman high-impedance thermistors). The phantom was positioned in the 24-antenna applicator SIGMA-Eye employing the integrated water bolus (filled with deionized water) both for coupling the radiated power into the lossy medium and to enable a correction procedure based on direct temperature measurements. RESULTS: In eight phantom experiments we monitored the heating in the applicator not only by repetitive acquisition of three-dimensional MR datasets, but also by measuring temperature-time curves directly at selected spatial positions. For the correction, we specified regions in the bolus. Direct bolus temperatures at fixed positions were taken to aim at best possible agreement between MR temperatures and these direct temperature-time curves. Then we compared additional direct temperature-position scans (thermal maps) for each experiment with the MR temperatures along these probes, which agreed satisfactorily (averaged accuracy of +/- 0.4-0.5 degrees C). The deviations decreased with decreasing observation time, temperature increase, and thermal load to the surroundings (corresponding to bolus heating)-estimating a resolution of, at best, +/- 0.2-0.3 degrees C. The acquired MR temperature distributions give also insight into limitations and control possibilities of regional hyperthermia (annular phased array technology) for various tumor sites. CONCLUSIONS: On-line MR monitoring of regional hyperthermia by using the PFS method is feasible in a phantom setup and can be further developed for clinical applications.

Feasibility Studies↗
PubMed2005

Peripheral vascular disease: carotid and vertebral brachytherapy for in-stent restenosis.

For years, intra-arterial brachytherapy has been a recognized method for treating recurrent stenosis after percutaneous transluminal angioplasty and stent placement. However, its use in arteries supplying the brain has not been described to date. We report a case treated with intra-arterial brachytherapy for high-grade recurrent stenoses of the high cervical internal carotid artery and the proximal vertebral artery. At 2-year follow-up, the outcome was successful.

Aged↗
PubMed2005

In vitro validation of phase-contrast flow measurements at 3 T in comparison to 1.5 T: precision, accuracy, and signal-to-noise ratios.

PURPOSE: To evaluate the signal-to-noise ratio (SNR), precision, and accuracy of phase-contrast flow measurements at 3 T with the help of an in vitro model and to compare the results with data from two 1.5-T scanners. MATERIALS AND METHODS: Using an identical setup of a laminar flow model and sequence parameters, measurements were done at one 3-T and at two 1.5-T systems. Precision, accuracy, and SNR were obtained for velocity encodings ranging from 55 up to 550 cm(-1). SNRs were calculated from the magnitude as well as the flow encoded images. RESULTS: Precision and accuracy for the in vitro flow model were similarly high in all scanners with no significant difference. For velocity encodings from 55 cm(-1) up to 550 cm(-1), the SNR in magnitude as well as phase encoded images of the 3-T measurements was approximately 2.5 times higher than the SNR obtained from the two 1.5-T systems. CONCLUSION: Even without optimization for the 3-T environment, flow measurements show the same high accuracy and precision as is known from clinical 1.5-T scanners. The superior SNR at 3 T will allow further improvements in temporal and spatial resolution. This will be of interest for small-size vessels like coronary arteries or for slow diastolic flow patterns.

Blood Flow Velocity↗
PubMed2005

Regional hyperthermia in conjunction with definitive radiotherapy against recurrent or locally advanced prostate cancer T3 pN0 M0.

BACKGROUND AND PURPOSE: Since long-term results of the standard treatment of locally advanced or recurrent prostatic carcinoma are unsatisfactory, the role for additional regional hyperthermia was evaluated in a phase I/II study. PATIENTS AND METHODS: From 08/1996 to 03/2000, 22 patients were treated by a standard irradiation regimen (68.4 Gy) in combination with regional hyperthermia (weekly, five to six times), and five of 22 patients received short-term (neoadjuvant) hormonal treatment. Of these, 15 patients had primary prostatic carcinoma T3 pN0 M0 and seven a histologically confirmed local recurrence after radical prostatectomy. Feasibility of hyperthermia, and acute/late toxicity as well as long-term follow-up (prostate- specific antigen [PSA] control, overall survival) were analyzed. Clinical endpoints were correlated with thermal parameters. RESULTS: Mean maximum temperatures along the urethra of 41.4 degrees C (41.0 degrees C for the recurrences), and mean T(90) values of 40.7 degrees C could be achieved. Severe acute toxicity of grade 3 occurred at the rectum in three, at the urethra in four, at the intestine in one, and a burn induced by hyperthermia in one of 22 patients. Late toxicity was only observed rectally in one patient (grade 3) and at the urethra in two patients (grade 2). There was no correlation between thermal parameters and any toxicity. The survival curves showed a PSA control for primary prostatic carcinoma > 50% after 6 years, but no long-term PSA control for the recurrences. Overall survival after 6 years was 95% for primary carcinoma, and 60% for the recurrences. There was a clear correlation between higher temperatures or thermal doses with long-term PSA control. CONCLUSION: Regional hyperthermia might be a low-toxicity approach to increase PSA control of common treatment schedules. Further evaluation, in particular employing improved hyperthermia technology, is worthwhile.

Aged↗