Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.

Detailed Description
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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 an open-label, single group assignment study. 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 32 patients will be accrued for this study for 84 months.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: fulvestrant


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fulvestrant<br>Fulvestrant will be provided as 250 mg in 5 mL as a pre-tilled syringe. Fulvestrant will be administered as 500 mg, that is, 2 injections of 5 mL, one into each buttock im on day 0. A single 250 mg in 5 mL injection will be administered on day 14 followed by a single 250 mg in 5 mL dose on day 28 and monthly thereafter. | Drug: fulvestrant<br>* intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who Respond to Treatment. | Response is defined to be the clear slowing of the rate of increase of PSA levels with time | 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Progressive Disease at Day +90 | Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value | 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer