Trial Outcomes & Findings for Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer (NCT NCT00515112)
NCT ID: NCT00515112
Last Updated: 2014-06-11
Results Overview
Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
TERMINATED
PHASE2
6 participants
Up to 5 years
2014-06-11
Participant Flow
Participant milestones
| Measure |
Androgel
Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily
|
Placebo
Three subjects received the placebo
Placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Androgel
Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily
|
Placebo
Three subjects received the placebo
Placebo: placebo
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
The study was terminated
|
3
|
2
|
Baseline Characteristics
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Androgel
n=3 Participants
Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily
|
Placebo
n=3 Participants
Three subjects received the placebo
Placebo: placebo
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: This study has been terminated due to poor accrual.
Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 8 weeksThe AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.
Outcome measures
Outcome data not reported
Adverse Events
Androgel
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Androgel
n=3 participants at risk
Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily
|
Placebo
n=3 participants at risk
Three subjects received the placebo
Placebo: placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
33.3%
1/3
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3
|
33.3%
1/3
|
|
Investigations
Blood bicarbonate decreased
|
33.3%
1/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Coarse hair
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dark stools
|
0.00%
0/3
|
33.3%
1/3
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3
|
33.3%
1/3
|
|
General disorders
Fatigue
|
33.3%
1/3
|
33.3%
1/3
|
|
Investigations
Hemoglobin
|
66.7%
2/3
|
33.3%
1/3
|
|
Investigations
Hemoglobin decreased
|
33.3%
1/3
|
33.3%
1/3
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/3
|
33.3%
1/3
|
|
Investigations
Hyperglycemia
|
0.00%
0/3
|
33.3%
1/3
|
|
Investigations
Hyperkalemia
|
0.00%
0/3
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3
|
66.7%
2/3
|
|
Investigations
Hypophosphatemia
|
0.00%
0/3
|
33.3%
1/3
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/3
|
33.3%
1/3
|
|
Psychiatric disorders
Libido decreased
|
33.3%
1/3
|
0.00%
0/3
|
|
Investigations
Lymphopenia
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
0.00%
0/3
|
|
General disorders
Pain- other: shoulder and back pain
|
0.00%
0/3
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3
|
0.00%
0/3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
33.3%
1/3
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3
|
33.3%
1/3
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/3
|
33.3%
1/3
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place