Trial Information

A Randomized Trial of Short Versus Long Acting LHRH Agonist Preparation Prior to Transperineal Implantation of the Prostate

The suppression of testosterone to castrate levels has a definite advantage in terms of
prostate volume downsizing, disease control and ease of Brachytherapy, in this patient
population. The improved potency preservation rate seen with brachytherapy, when compared
to other treatments such as radical prostatectomy or external beam, may be an important
determinant in the patient's choice of treatment modality. Hence, testosterone recovery
should be an important endpoint to consider in this patient population since prolongation of
testosterone suppression may also delay the return of erectile function.

In order to compare the impact of LHRH agonist preparations on the rate of testosterone
recovery, we propose a randomized clinical trial using one versus three-month Leuprolide
preparations in patients otherwise suitable for our Brachytherapy Program.

The primary objective of this study is the median time to testosterone recovery in patients
receiving 6 X 1-month or 2 X 3-month LHrH preparations and TPIP as radical treatment for
limited stage prostate cancer.

In this context, testosterone recovery is defined as the return to the lower limit of normal
for the patient's age group as well as return to pre treatment levels.

Analysis will mainly focus on time to testosterone recovery as defined by return to the
lower limit of normal for the patient's age group as well as return to pre treatment levels.
The lower limits of normal are defined as 5.8nmol/L and 5.5nmol/L for < 50 and > 50 years
old

Changes in PSA level, QOL and erectile function will also be recorded