Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer
Brief summary
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
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.
Interventions
intramuscularly
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Respond to Treatment. | 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment | Response is defined to be the clear slowing of the rate of increase of PSA levels with time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progressive Disease at Day +90 | 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment | Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fulvestrant Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.
fulvestrant: intramuscularly | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 2 |
| Overall Study | Progression | 15 |
Baseline characteristics
| Characteristic | Fulvestrant |
|---|---|
| Age, Continuous | 63.01 years STANDARD_DEVIATION 8.98 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
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
Time frame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
Population: All treated and eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fulvestrant | Proportion of Patients Who Respond to Treatment. | 0 percentage of participants |
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
Time frame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
Population: All treated and eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fulvestrant | Number of Participants With Progressive Disease at Day +90 | 15 participants |