Clinical trial NCT00140478: Mifepristone (RU-486) in Androgen Independent Prostate Cancer
Official title: A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Adenocarcinoma of Prostate
Keywords: Androgen Independent Prostate Cancer
Prostate Cancer
Mifepristone
RU-486
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
name: Brigham and Women's Hospital
name: Georgetown University
First posted: 2005-09-01
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.

Detailed description: Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.

At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.

After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.

Eligibility criteria: Inclusion Criteria:

* Histologic documentation of adenocarcinoma of the prostate
* Bone metastasis(es) by bone scan or cat scan
* Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
* One prior chemotherapy treatment is allowed.
* \> 3 weeks since major surgery
* \> 4 weeks since radiotherapy
* \> 8 weeks since prior strontium-89 or samarium 153
* ECOG performance status 0 or 1
* Absolute neutrophil count (ANC) \> 1,500/ul
* Platelets \> 100,000/ul
* Bilirubin \< 1.5 x upper limit of normal (ULN)
* AST or ALT \< 3 x ULN
* Creatinine \< 1.5 x ULN
* Electrolytes within 10% of normal range
* Serum testosterone \< 50ng/dL
* Prostate-specific antigen (PSA) \> 5.0ng/ml

Exclusion Criteria:

* Concomitant therapy with corticosteroids
* Chemotherapy within 28 days
* Currently active second malignancy other than non-melanoma skin cancer
* Baseline adrenal insufficiency requiring long-term steroids

Primary outcomes:
measure: To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
timeFrame: 2 years
Secondary outcomes:
measure: To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary-Ellen Taplin, MD
role: PRINCIPAL_INVESTIGATOR
References: