Phase 2 N=10 Treatment

Fulvestrant in Hormone Refractory Prostate Cancer

Prostatic Neoplasms · Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00476645 ↗

Enrolled (actual)

Serious AEs

30.0%

Results posted

Aug 2014

Primary outcome: Primary: PSA Reduction ≥ 50% — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fulvestrant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Stanford University
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY PSA Reduction ≥ 50%	—	—
SECONDARY PSA Doubling Time	3	—
SECONDARY Stable Disease After One Year	1	—

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).

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00476645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.