A Phase II Trial of Perifosine (IND 58,156; NSC# 639966) in Biochemically Recurrent, Hormone Sensitive Prostate Cancer

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
prostate

- Patients must have a rising PSA >= 2.0 following a nadir after local curative therapy
(either radical prostatectomy and/or pelvic radiation) with no clinical or
radiographic evidence of metastatic disease; PSA >= 2.0 elevation must be confirmed
by two consecutive increases, each measured at least 2 weeks apart; only patients
with a biochemical (PSA) recurrence with no physical exam or radiographic evidence of
local or distant relapse are eligible

- Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as
long as neither lasted for more than 9 months; androgen deprivation therapy must have
been completed at least one year prior to registration; patients could not have had a
rising PSA at the time that neoadjuvant or adjuvant therapy was stopped

- Life expectancy of greater than 3 months

- Karnofsky performance status > 60%

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,00/uL

- Total bilirubin =< 1.5 mg/dL

- AST (SGOT)/ALT (SGPT) =< 2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

- Computed tomography scan or MRI of the pelvis negative for metastatic disease within
3 months prior to registration

- Bone scan negative for metastatic disease within 3 months prior to registration

- Chest PA and lateral films negative for metastatic disease within 3 months prior to
registration

- Prior vaccine therapy is allowed if completed at least 6 months prior to registration

- Men enrolled in this trial must agree to use adequate contraception prior to study
entry and for the duration of study participation

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had any prior cytotoxic chemotherapy

- Patients may not be receiving any other investigational agents

- Patients receiving concurrent chemotherapeutic agents, biological response modifiers,
radiation therapy, corticosteroid or hormonal therapy; no complementary or
alternative therapy (e.g., St. John's Wort, PC-SPES, or any other herbal remedies
taken for the purpose of treating prostate cancer) may be given during protocol
treatment

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to perifosine

- Androgen deprivation given for reasons other than neoadjuvant or adjuvant therapy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with perifosine;
appropriate studies will be undertaken in patients receiving combination
anti-retroviral therapy when indicated

- No prior malignancy is allowed except for the following: adequately treated basal
cell or squamous cell skin cancer, in situ carcinoma of any site, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years