Pd-103 Dose De-Escalation for Early Stage Prostate Cancer in Low Risk Subjects: A Prospective Randomized Trial

The purpose of this study is to determine the most appropriate radiation implant dose for palladium-103 monotherapy in low risk patients (Gleason ≤ 6, PSA ≤ 10, DRE < T2c).  Radiation dose is related to potential cure.  From previously published studies, it appears that the prescribed radiation dose can be reduced by 15-20% without any difference in potential cure (in this study, the dose is being decreased by 12%).  Although most patients tolerate brachytherapy well, complications do appear to be related to radiation exposure to normal structures (i.e. urethra, rectum and proximal penis).  By reducing the prescribed dose, it is conceivable that fewer patients will experience side effects and complications, or that side effects that do occur are of lesser magnitude.

The purpose of this research program is to develop improved methods of treatment in your disease.  Although it is our hope that you will benefit directly from participation in this study and that other patients may also benefit from an increased understanding of this approach to therapy, we cannot at present state that your participation will be directly beneficial to you.

Prior to implantation, you will be randomized to either 125 Gy or 110 Gy prescription dose.

A Pd-103 implant of your prostate gland will be performed by conventional methods which have already been described to you as part of routine care. 

To compare the effectiveness of the Pd-103 implant, you will be closely monitored during and after the completion of your treatment.  After your implant, repeat PSA blood tests will be obtained at 3 months and then every 6 months for 6 years.  The total length of the study will be 6 years.

For further information please contact: research@seattleprostate.com