Trial Outcomes & Findings for Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer (NCT NCT00176644)
NCT ID: NCT00176644
Last Updated: 2023-09-13
Results Overview
PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
3 years
Results posted on
2023-09-13
Participant Flow
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 4 community hospitals within the Cancer Institute of New Jersey Oncology Group from May 2005 through April 2008.
Participant milestones
| Measure |
Transdermal Estradiol
Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Transdermal Estradiol
Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Transdermal Estradiol
n=23 Participants
Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.
Outcome measures
| Measure |
Transdermal Estradiol
n=23 Participants
Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
|
|---|---|
|
Percentage of Patients With PSA Response
|
8.7 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate
Outcome measures
Outcome data not reported
Adverse Events
Transdermal Estradiol
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transdermal Estradiol
n=23 participants at risk
Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
Blood and lymphatic system disorders
Platelets
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
|
Investigations
Alkaline phosphatase
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
|
Nervous system disorders
Neuropathy: sensory
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
|
General disorders
Pain - Bone
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
|
Renal and urinary disorders
Obstruction, GU - Urethra
|
4.3%
1/23 • Number of events 1 • 3 years and 6 months
|
Other adverse events
| Measure |
Transdermal Estradiol
n=23 participants at risk
Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
|
|---|---|
|
General disorders
Pain - Bone
|
13.0%
3/23 • Number of events 3 • 3 years and 6 months
|
|
General disorders
Pain - Breast
|
13.0%
3/23 • Number of events 3 • 3 years and 6 months
|
|
General disorders
Pain - Extremity-limb
|
13.0%
3/23 • Number of events 3 • 3 years and 6 months
|
|
General disorders
Pain - Back
|
13.0%
3/23 • Number of events 3 • 3 years and 6 months
|
|
General disorders
Pain - Neck
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
General disorders
Pain - Other (Specify, __)
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
21.7%
5/23 • Number of events 5 • 3 years and 6 months
|
|
General disorders
Sweating (diaphoresis)
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23 • Number of events 3 • 3 years and 6 months
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.7%
2/23 • Number of events 5 • 3 years and 6 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
13.0%
3/23 • Number of events 5 • 3 years and 6 months
|
|
Nervous system disorders
Neuropathy: sensory
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.7%
2/23 • Number of events 2 • 3 years and 6 months
|
Additional Information
Dr. Mark Stein
Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place