Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active Any age Pharmaceutical / Industry RPCI-I-17203 RPCI-PH-17203, ZENECA-IRUSFULV0026, NCT00217464

Objectives

Primary

1. 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

1. Determine the utility of monitoring serum PSA in patients treated with this drug.
2. Determine the safety of this drug in these patients.
3. Determine changes in bone mineral density and markers of bone resorption in patients with PSA-only failure treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate
  • Early recurrent disease, defined by 1 of the following criteria:
    • Prostate-specific antigen (PSA) ≥ 2.0 ng/mL AND clearly rising within the past 3 months for patients who underwent prior prostatectomy with or without radiotherapy
    • PSA ≥ 4.0 ng/mL AND clearly rising from the lowest value obtained within the past 6 months for patients who underwent prior definitive radiotherapy only



• No evidence of clinical recurrence,* as defined by the following criteria:
  • Digital rectal exam negative
  • No local recurrence by CT scan or MRI of the pelvis
  • No evidence of bone metastasis by bone scan

   [Note: *Prostascint scan results are not considered evidence of recurrence]




• Underwent prior curative treatment comprising radical prostatectomy with or without adjuvant radiotherapy OR definitive radiotherapy alone



• Testosterone (total or free) > than lower limit of normal

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• More than 6 months since prior neoadjuvant or adjuvant androgen deprivation therapy or luteinizing hormone-releasing hormone antagonist therapy
• No other prior or concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• No concurrent radiotherapy

Surgery

• See Disease Characteristics

Other

• More than 4 weeks since prior experimental drug treatment
• No concurrent anticoagulant therapy except antiplatelet therapy
• No other concurrent therapy for prostate cancer
• No other concurrent therapy known or suspected of altering androgen metabolism or androgen levels

Patient Characteristics:

Age

• Any age

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC > 3,500/mm³
• Platelet count > 100,000/mm³
• No history of bleeding diathesis

Hepatic

• INR < 1.6
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT or AST ≤ 2.5 times ULN
• No severe hepatic impairment that would preclude study participation or compliance

Renal

• Creatinine ≤ 2.0 mg/dL
• No severe renal impairment that would preclude study participation or compliance

Cardiovascular

• No unstable or uncompensated cardiac condition that would preclude study participation or compliance

Pulmonary

• No unstable or uncompensated respiratory condition that would preclude study participation or compliance

Other

• Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study treatment
• No history of hypersensitivity to active or inactive excipients of fulvestrant (e.g., castor oil)
• No other severe condition that would preclude study compliance (e.g., abuse of alcohol or drugs or psychotic states) or participation

Expected Enrollment

A total of 56 patients (28 per stratum) will be accrued for this study within 3 years.

Outcomes

Whether fulvestrant can slow the rise in prostate-specific antigen (PSA) for survival

Utility of serum PSA in monitoring treatment effect of fulvestrant for survival

Outline

This is a parallel group study. Patients are stratified according to prior primary therapy (prostatectomy with or without radiotherapy vs definitive radiotherapy alone).

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Donald Trump, MD, Principal investigator		Ph: 716-845-3499; 800-685-6825 Email: donald.trump@roswellpark.org

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724

Registry Information
Official Title		Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial
Trial Start Date		2004-06-21
Trial Completion Date		2013-01-18 (estimated)
Registered in ClinicalTrials.gov		NCT00217464
Date Submitted to PDQ		2005-07-22
Information Last Verified		2008-08-28
NCI Grant/Contract Number		CA16056