Trial Information

Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition in a Phase III Randomized Trial

Primary Objectives:

1. To compare CAS and IAS with respect to bone mineral density (BMD): We will determine
whether the bone loss associated with long term CAS can be reduced by IAS by evaluation
of:

1. BMD,

2. biochemical markers of bone formation/resorption,

3. skeletal relevant events (SRE) (defined as pathological fracture, symptomatic
hypercalcemia or hypocalcemia, spinal cord compression, or need of spinal orthosis
for vertebral deformity or collapse).

2. To compare CAS and IAS with respect to body composition: We will determine whether the
reduction in muscle mass and increased fat accumulation associated with long term CAS
can be reduced by IAS. We will evaluate:

1. percentage fat body mass,

2. percentage lean body mass and

3. body mass index.

3. To evaluate the predictive value of germline polymorphisms in the Vitamin D receptor
(VDR) gene for bone loss

Eligible Patients for PR.7:

1. Histologically confirmed prostate cancer (PCa)

2. Completed radiotherapy to the prostatic area more than 12 months prior to randomization

3. Rising prostate specific antigen (PSA) level (serum PSA > 3 ng/ml (3 μg/L)) and higher
than the lowest level recorded previously since the end of radiotherapy (i.e. higher
than the post-radiotherapy nadir)

4. No definite evidence of distant metastasis (radiological changes compatible with
non-malignant diseases are acceptable)

5. No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to
radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed
at least 12 months prior to randomization

Evaluation during protocol treatment will take place to assess differences in BMD, body
composition, biochemical and genetic markers of bone disease in the two groups.