OPEN: Efficacy trial (Phase II) regarding the use of nano-cancer therapy in prostate carcinoma

The standard therapy forms for early carcinoma of the prostate with intermediate risk are to be expanded through a combination of LDR brachytherapy (seed implantation with 145 Gy prescribed dosage) with nano-cancer therapy. This trial arm is supposed to be more effective than seed monotherapy, but on the other hand, is supposed to exhibit better tolerability and be at least as effective as seed combination therapy (prescribed dosage 110 Gy plus 45 Gy external radiation).

Study title

Efficacy study regarding thermotherapy with magnetic nanoparticles in combination with LDR brachytherapy (¹²⁵iodine seeds) for prostate carcinoma with intermediate risk

Primary investigator

Prof. Dr. Peter Wust, Clinic for Radiation Medicine, Charité University Medicine Berlin

Study start

January 2007

Inclusion criteria

• Biopsy-confirmed prostate carcinoma which is limited to the prostate (ultrasound, DRE)
  
• Patients with intermediate risk who decline radical prostatectomy or percutaneous radiation therapy as the therapy of first choice:
• T1c – T2a and Gleason-Score = 7 and PSA < 10 ng/ml
• T1c – T2a and Gleason-Score < 7 and PSA > 10 < 20 ng/ml
• T2b – T2c and Gleason-Score < 7 and PSA < 10 ng/ml

• If Gleason = 7, no more than half of the number of obtained punch cylinders can be infiltrated with carcinoma, since clinical understaging is otherwise assumed (cT1-cT2, but pT3)
• Karnofsky Index of ≥ 70
• Prostate volume ≤ 55 mL
• No metal parts (e.g. hip endoprosthesis) less than 40 cm away from the treatment zone
• No relevant obstruction (that is, IPSS ≤ 15)
• Patient has been provided with information, and there is a written declaration of consent
  

Exclusion criteria

• Synchronous or metachronous secondary tumors with the exception of controlled skin carcinoma
• Distant metastases (exclusion through skeletal scintigraphy or CT/MRT)
• Significant or symptomatic bladder emptying disturbances
• Known history of chronic inflammatory intestinal disorders with involvement of the rectum
  
• Cardiac pacemaker or defibrillator
• Simultaneous participation in another clinical trial
  

Closed: Feasibility trial (Phase I) regarding the use of nano-cancer therapy in RECURRING LOCAL PROSTATE CARCINOMA

From February 2004 to June 2006, a Phase I study was conducted on ten patients (previously treated prostate carcinoma). The study included patients with PSA elevation and histologically confirmed local progress without remote metastasis. The feasibility of the method was proven in all patients. Temperatures up to 50°C were obtained within the tumor. Only 25 percent of the available performance of the alternating magnetic field was utilized during the therapy. Therefore, more potential for reaching higher treatment temperatures seems to be available.