Clinical trial NCT00476645: Fulvestrant in Hormone Refractory Prostate Cancer
Official title: Fulvestrant in Hormone-refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-05-22
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).

Detailed description: The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.

Eligibility criteria: Inclusion Criteria:

* Must give signed written informed consent
* Must be of age 18 years or older
* Histologically confirmed adenocarcinoma of the prostate
* Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy
* Must have had rise in PSA despite anti-androgen withdrawal
* Must exhibit two consecutive rises in PSA after the last hormonal manipulation
* Minimum PSA \> 5mg/dL
* KPS \> 80%
* Up to one prior chemotherapy treatments allowed
* Life expectancy of greater than 6 months

Exclusion Criteria:

* Concomitant hormonal therapy other than an LHRH
* Noncompliance
* Platelets less than 100 x 10e9 /L
* International normalization ratio (INR) greater than 1.6
* Total bilirubin greater than 1.5 x ULRR
* ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases
* History of bleeding diathesis (ie, disseminated intravascular coagulation \[DIC\], clotting factor deficiency)
* History of long-term anticoagulant therapy (other than antiplatelet therapy)
* History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)

Primary outcomes:
measure: PSA Reduction ≥ 50%
timeFrame: 3 months
Secondary outcomes:
measure: PSA Doubling Time
timeFrame: 3 months
measure: Stable Disease After One Year
timeFrame: 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Sandy Srinivas
role: PRINCIPAL_INVESTIGATOR
References:
citation: Srinivas S, Harshman LC, Feldman D. "Effect of fulvestrant on PSA doubling time in patients with castration-resistant prostate cancer (CRPC)." JCO. Annual Meeting, ASCO 2010. 20 May 2010;28(15-suppl)(abs e15112).