Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: fulvestrant

• Registration Number: NCT00217464
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.

PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine whether fulvestrant can slow the rise of prostrate-specific antigen (PSA) level in patients with early recurrent adenocarcinoma of the prostate after radical prostatectomy or irradiation.

Secondary

* Determine the utility of monitoring serum PSA in patients treated with this drug.

* Determine the safety of this drug in these patients.

* Determine changes in bone mineral density and markers of bone resorption in patients with PSA-only failure treated with this drug.

OUTLINE: This is an open-label, single group assignment study.

Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study for 84 months.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Status Verified: 2015-03
• Results First Submitted: 2015-03-17
• Results First Submitted QC: 2015-03-31
• Last Update Submitted: 2015-03-31
• Results First Posted: 2015-04-16
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fulvestrant	fulvestrant	Fulvestrant will be provided as 250 mg in 5 mL as a pre-tilled syringe. Fulvestrant will be administered as 500 mg, that is, 2 injections of 5 mL, one into each buttock im on day 0. A single 250 mg in 5 mL injection will be administered on day 14 followed by a single 250 mg in 5 mL dose on day 28 and monthly thereafter.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Respond to Treatment.	90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment	Response is defined to be the clear slowing of the rate of increase of PSA levels with time

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Progressive Disease at Day +90	90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment	Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States