Clinical trial · Interventional
Fulvestrant in Hormone Refractory Prostate Cancer
Fulvestrant in Hormone-refractory Prostate Cancer
NCT00476645CI-TRIAL-00015316completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fulvestrant
- interventionNames
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- PSA Reduction ≥ 50%
- timeFrame
- 3 months
- description
- Number of subjects with serum PSA reduction ≥ 50% at 3 months
Secondary outcomes (2)
- measure
- PSA Doubling Time
- timeFrame
- 3 months
- description
- Number of subjects with prolongation of PSA doubling time
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTSrinivas 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).