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Phase II Trial to Assess the Activity of Ketoconazole Plus GM-CSF in Patients With Prostate Cancer Progressive After Androgen Deprivation

Phase 2
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Trial to Assess the Activity of Ketoconazole Plus GM-CSF in Patients With Prostate Cancer Progressive After Androgen Deprivation



- Evaluate the effect of ketoconazole, hydrocortisone, and sargramostim (GM-CSF) on time
to clinical progression in patients with prostate cancer that has progressed on primary
hormonal therapy.


- Evaluate the objective response frequency in patients treated with this regimen.

- Investigate the safety of this regimen.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive oral ketoconazole three times daily and oral hydrocortisone twice daily on
days 1-28 and sargramostim (GM-CSF) subcutaneously on days 15-28. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Progressive disease after androgen deprivation AND meets 1 of the following criteria:

- Measurable disease

- Measurable lesions ≥ 10 mm with spiral CT

- Up to 5 lesions per organ and 10 lesions total should be identified as
target lesions

- No measurable disease

- Patients with prostate-specific antigen (PSA)-only disease must have an
elevated PSA

- PSA evidence for progressive disease consists of a PSA level of ≥ 5
ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart

- Patients with a positive bone scan must also have an elevated PSA

- Patients who received prior antiandrogen as a part of primary androgen ablation
therapy must demonstrate disease progression after discontinuation of the

- Disease progression after antiandrogen withdrawal is defined as 2 consecutive
rising PSA values obtained ≥ 2 weeks apart, or documented osseous or soft tissue

- Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥
4 weeks after flutamide discontinuation

- Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA
values obtained ≥ 6 weeks after antiandrogen discontinuation

- Testosterone < 50 ng/dL

- PSA ≥ 5 ng/mL


- Karnofsky performance status 60-100%

- No serious intercurrent infections or nonmalignant uncontrolled medical illnesses

- No psychiatric illnesses OR social situations that would limit compliance

- No active or uncontrolled autoimmune disease

- ALT and AST normal

- Bilirubin normal

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit or normal (ULN)

- Hemoglobin ≥ 8 g/dL

- No other currently active malignancy except for nonmelanoma skin cancer

- No currently active malignancy defined as therapy completed with ≤ 30% risk of


- See Disease Characteristics

- Patients must continue primary androgen deprivation therapy with a
luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone

- No prior systemic chemotherapy for prostate cancer

- All other systemic chemotherapy must have been completed ≥ 2 years prior to

- No other concurrent chemotherapy, immunotherapy, or radiotherapy

- Major surgery or radiation therapy completed ≥ 4 weeks prior to study

- No other concurrent corticosteroids, including routine use antiemetics

- No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of
progressive prostate cancer

- No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF)

- Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal
product known to decrease PSA levels [e.g., saw palmetto or PC-SPES], or any systemic
corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and
progressive disease must be documented after discontinuation

- No initiation of bisphosphonate therapy within 1 month prior to starting study

- Patients on stable doses that show tumor progression are allowed to continue

- No concurrent supplements or complementary medicines/botanicals, except any
combination of the following:

- Conventional multivitamin supplements

- Selenium

- Lycopene

- Soy supplements

- Vitamin E

- At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium
Sm 153 lexidronam pentasodium)

- No other concurrent investigational or commercial anticancer agents or therapies

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Safety Issue:


Principal Investigator

Charles Ryan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

December 2007

Related Keywords:

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



Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
UCSF Comprehensive Cancer CenterSan Francisco, California  94115