Trial Outcomes & Findings for Fulvestrant in Treating Patients With Recurrent Prostate Cancer (NCT NCT00217464)

NCT ID: NCT00217464

Last Updated: 2015-04-16

Results Overview

Response is defined to be the clear slowing of the rate of increase of PSA levels with time

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
• Results posted on: 2015-04-16

Participant Flow

Participant milestones

Measure	Fulvestrant Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. fulvestrant: intramuscularly
Overall Study STARTED	17
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Fulvestrant Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. fulvestrant: intramuscularly
Overall Study Progression	15
Overall Study Other	2

Baseline Characteristics

Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Baseline characteristics by cohort

Measure	Fulvestrant n=17 Participants Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. fulvestrant: intramuscularly
Age, Continuous	63.01 years STANDARD_DEVIATION 8.98 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment

Population: All treated and eligible patients

Response is defined to be the clear slowing of the rate of increase of PSA levels with time

Outcome measures

Measure	Fulvestrant n=17 Participants Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. fulvestrant: intramuscularly
Proportion of Patients Who Respond to Treatment.	0 percentage of participants Interval 0.0 to 18.4

SECONDARY outcome

Timeframe: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment

Population: All treated and eligible patients

Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value

Outcome measures

Measure	Fulvestrant n=17 Participants Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. fulvestrant: intramuscularly
Number of Participants With Progressive Disease at Day +90	15 participants

Adverse Events

Fulvestrant

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fulvestrant n=17 participants at risk Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. fulvestrant: intramuscularly
Investigations Blood alkaline phosphatase increased	5.9% 1/17 • Number of events 1
Metabolism and nutrition disorders Hyponatraemia	5.9% 1/17 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • Number of events 1
Psychiatric disorders Confusional state	5.9% 1/17 • Number of events 1

Other adverse events

Measure	Fulvestrant n=17 participants at risk Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. fulvestrant: intramuscularly
Blood and lymphatic system disorders Anaemia	5.9% 1/17 • Number of events 1
Blood and lymphatic system disorders Leukopenia	5.9% 1/17 • Number of events 1
Blood and lymphatic system disorders Neutropenia	5.9% 1/17 • Number of events 1
Gastrointestinal disorders Constipation	5.9% 1/17 • Number of events 1
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Number of events 2
Gastrointestinal disorders Nausea	11.8% 2/17 • Number of events 2
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 1
General disorders Fatigue	11.8% 2/17 • Number of events 2
General disorders Injection site inflammation	5.9% 1/17 • Number of events 1
General disorders Injection site pain	52.9% 9/17 • Number of events 9
General disorders Injection site reaction	5.9% 1/17 • Number of events 1
Hepatobiliary disorders Hyperbilirubinaemia	5.9% 1/17 • Number of events 1
Investigations Alanine aminotransferase increased	5.9% 1/17 • Number of events 1
Investigations Aspartate aminotransferase increased	5.9% 1/17 • Number of events 1
Metabolism and nutrition disorders Hypercalcaemia	11.8% 2/17 • Number of events 2
Metabolism and nutrition disorders Hyperglycaemia	17.6% 3/17 • Number of events 3
Metabolism and nutrition disorders Hyperkalaemia	29.4% 5/17 • Number of events 6
Metabolism and nutrition disorders Hypernatraemia	23.5% 4/17 • Number of events 5
Metabolism and nutrition disorders Hypoglycaemia	5.9% 1/17 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • Number of events 1
Musculoskeletal and connective tissue disorders Buttock pain	5.9% 1/17 • Number of events 1
Nervous system disorders Dizziness	11.8% 2/17 • Number of events 2
Nervous system disorders Headache	11.8% 2/17 • Number of events 2
Renal and urinary disorders Haematuria	5.9% 1/17 • Number of events 1
Renal and urinary disorders Micturition urgency	11.8% 2/17 • Number of events 2
Renal and urinary disorders Pollakiuria	5.9% 1/17 • Number of events 1
Reproductive system and breast disorders Erectile dysfunction	5.9% 1/17 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Number of events 1
Skin and subcutaneous tissue disorders Acne	5.9% 1/17 • Number of events 1
Skin and subcutaneous tissue disorders Hyperhidrosis	11.8% 2/17 • Number of events 2
Vascular disorders Hot flush	5.9% 1/17 • Number of events 1

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place