title: Morbidity and quality of life during thermotherapy using magnetic nanoparticles in locally recurrent prostate cancer: results of a prospective phase I trial.
abstract: OBJECTIVE
  To investigate the treatment-related morbidity and quality of life (QoL) during thermotherapy using superparamagnetic nanoparticles in patients with locally recurrent prostate cancer.
  
  
  METHODS
  Ten patients with biopsy-proven locally recurrent prostate cancer following primary therapy with curative intent and no detectable metastases were entered on a prospective phase I trial. Endpoints were feasibility, toxicity and QoL. Following intraprostatic injection of a nanoparticle dispersion, six thermal therapy sessions of 60 min duration were delivered at weekly intervals using an alternating magnetic field. National Cancer Institute (NCI) common toxicity criteria (CTC) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-PR25 questionnaires were used to evaluate toxicity and QoL, respectively. In addition, prostate specific antigen (PSA) measurements were carried out.
  
  
  RESULTS
  Maximum temperatures up to 55 degrees C were achieved in the prostates at 25-30% of the available magnetic field strength. Nanoparticle deposits were detectable in the prostates one year after thermal therapy. At a median follow-up of 17.5 months (3-24), no systemic toxicity was observed. Acute urinary retention occurred in four patients with previous history of urethral stricture. Treatment-related morbidity was moderate and QoL was only temporarily impaired. Prostate-specific antigen (PSA) declines were observed in eight patients.
  
  
  CONCLUSIONS
  Interstitial heating using magnetic nanoparticles was feasible and well tolerated in patients with locally recurrent prostate cancer. Deposition of nanoparticles in the prostate was highly durable. Further refinement of the technique is necessary to allow application of higher magnetic field strengths.
authors.affiliation: Department of Urology, Charité-Universitätsmedizin, Berlin, Germany. manfred.johannsen@charite.de
authors.forename: M
authors.initials: M
authors.lastname: Johannsen
authors.forename: U
authors.initials: U
authors.lastname: Gneveckow
authors.forename: K
authors.initials: K
authors.lastname: Taymoorian
authors.forename: B
authors.initials: B
authors.lastname: Thiesen
authors.forename: N
authors.initials: N
authors.lastname: Waldöfner
authors.forename: R
authors.initials: R
authors.lastname: Scholz
authors.forename: K
authors.initials: K
authors.lastname: Jung
authors.forename: A
authors.initials: A
authors.lastname: Jordan
authors.forename: P
authors.initials: P
authors.lastname: Wust
authors.forename: S A
authors.initials: SA
authors.lastname: Loening
mesh_terms: D000368:Aged; D005500:Follow-Up Studies; D006306:Health Surveys; D006801:Humans; D006979:Hyperthermia, Induced / Q000295:instrumentation / Q000379:methods*; D008280:Magnetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D053758:Nanoparticles / Q000627:therapeutic use*; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D011788:Quality of Life; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome