Prostate Cancer Clinical Trial
Official title:
Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition in a Phase III Randomized Trial
The purpose of this study is to determine, in patients entered on the National Cancer
Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation,
whether the rates of osteoporosis, fractures, and alteration in body composition are reduced
by intermittent androgen ablation.
There will be two groups of patients:
1. A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002,
randomized between intermittent androgen suppression (IAS) and continuous androgen
suppression (CAS) (75 from each group). Patients who have definite bone metastases are
excluded from this study. Biochemical failure does not exclude the patient.
2. A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75
from each group). These patients will have baseline evaluation of bone loss and body
composition, longitudinal monitoring and follow-up on an annual basis for patients on
CAS and at the end of each “off cycle” of IAS. Patients taking bisphosphonates are
excluded from this study.
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.
;
Primary Purpose: Screening, Time Perspective: Longitudinal
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |