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Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial


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 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.

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

Inclusion 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

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- WBC > 3,500/mm^3

- Platelet count > 100,000/mm^3

- 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

- 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

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Monthly

Safety Issue:

No

Principal Investigator

Donald L. Trump, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000441210

NCT ID:

NCT00217464

Start Date:

June 2004

Completion Date:

March 2010

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263