Trial Outcomes & Findings for Fulvestrant in Hormone Refractory Prostate Cancer (NCT NCT00476645)

NCT ID: NCT00476645

Last Updated: 2014-08-05

Results Overview

Number of subjects with serum PSA reduction ≥ 50% at 3 months

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2014-08-05

Participant Flow

Participant milestones

Measure	Fulvestrant 250 mg IM fulvestrant (250 mg) day 1 \& day 14 of 1st month, then monthly
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fulvestrant in Hormone Refractory Prostate Cancer

Baseline characteristics by cohort

Measure	Fulvestrant 250 mg n=10 Participants IM fulvestrant (250 mg) day 1 \& day 14 of 1st month, then monthly
Age, Continuous	75 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All subjects (10 males) had castration-resistant prostate cancer. 6 had recieved prior radical prostatectomy as primary therapy. 4 had received prior chemotherapy. The majority had previously received 2 hormonal therapies. 2 had recieved radiation therapy, and 2 had recieved hormonal monotherapy.

Number of subjects with serum PSA reduction ≥ 50% at 3 months

Outcome measures

Measure	Fulvestrant 250 mg n=10 Participants IM fulvestrant (250 mg) day 1 \& day 14 of 1st month, then monthly
PSA Reduction ≥ 50%	0 participants

SECONDARY outcome

Timeframe: 3 months

Number of subjects with prolongation of PSA doubling time

Outcome measures

Measure	Fulvestrant 250 mg n=10 Participants IM fulvestrant (250 mg) day 1 \& day 14 of 1st month, then monthly
PSA Doubling Time	3 participants

SECONDARY outcome

Timeframe: 12 months

Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria.

Outcome measures

Measure	Fulvestrant 250 mg n=10 Participants IM fulvestrant (250 mg) day 1 \& day 14 of 1st month, then monthly
Stable Disease After One Year	1 participants

Adverse Events

Fulvestrant 250 mg

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fulvestrant 250 mg n=10 participants at risk IM fulvestrant (250 mg) day 1 \& day 14 of 1st month, then monthly
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	10.0% 1/10 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Edema	10.0% 1/10 • Number of events 2 • 12 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Intermittent tiny sensitive area on forehead (sligh	10.0% 1/10 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	10.0% 1/10 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 1 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor of Medicine (Oncology)

Stanford University Medical Center

Phone: 650-725-2078

Email: sandysri@stanford.edu

Results disclosure agreements

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