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Randomized Phase II Trial of Docetaxel With or Without PSA-TRICOM Vaccine in Patients With Castrate-Resistant Metastatic Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

Randomized Phase II Trial of Docetaxel With or Without PSA-TRICOM Vaccine in Patients With Castrate-Resistant Metastatic Prostate Cancer


I. To evaluate the overall survival in patients treated with PSA-TRICOM and docetaxel
chemotherapy versus docetaxel chemotherapy only.


I. To evaluate the time to radiographic progression after beginning docetaxel chemotherapy
in patients previously treated with PSA-TRICOM vaccine versus those not treated with this

II. To compare objective responses (according to RECIST) between the two treatment groups in
those patients with measurable disease.

III. To evaluate PSA response rates (decline > 50%) in patients treated with PSA-TRICOM and
docetaxel chemotherapy versus docetaxel chemotherapy only.

IV. To evaluate immune responses elicited in patients treated before and after docetaxel

V. To evaluate the association between development of prostate antigen-specific immune
responses and time to progression and overall survival.

VI. To evaluate the association of predicted survival (by Halabi nomogram) with actual
survival in patients treated with PSA-TRICOM vaccine versus those not treated with this

OUTLINE: This is a multicenter study. Patients are stratified according to disease
progression (PSA vs radiographic criteria), extraskeletal metastases (yes vs no), and prior
bisphosphonate (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I (vaccine and chemotherapy): Patients receive vaccinia-PSA(L155)-TRICOM vaccine
subcutaneously (SC) on day 1 of course 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15,
29, 43, and 57 of course 1. Beginning on day 85 (day 1 of course 2), patients receive
docetaxel intravenously (IV) over 1 hour on day 1 and prednisone orally (PO) twice daily on
days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12
courses in the absence of disease progression or unacceptable toxicity.

ARM II (chemotherapy): Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO
twice daily on days 1-21. Treatment repeats every 21 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity.

Some patients undergo blood sample collection to measure frequency of PSA-specific T-cells
and other biomarkers of immune response.

After completion of study therapy, patients are followed up every 3-6 months for 5 years.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Evidence of metastatic disease by the presence of soft tissue and/or bone
metastases on CT scan of the abdomen and/or pelvis, or bone scintigraphy

- Castrate-resistant disease defined by the following:

- Must have received standard-of-care androgen-deprivation treatment (ADT) (e.g.,
surgical castration, gonadotropin-releasing hormone [GnRH], or antagonist

- Patients on concurrent GnRH analogue or antagonist must continue on this
treatment throughout this study

- Must have been treated with nonsteroidal antiandrogen with evidence of
subsequent disease progression

- Must have castration levels of testosterone (< 50 ng/dL) within the past 4 weeks

- Progressive disease while receiving ADT, defined by any 1 of the following:

- At least 2 consecutive rises in serum PSA (each value ≥ 2.0 ng/mL) obtained at a
minimum of 1-week intervals

- Measurable disease with ≥ 50% increase in the sum of the cross products of all
measurable lesions, or the development of new measurable lesions by RECIST

- The greatest diameter of a target lymph node must be ≥ 2 cm with
conventional techniques or ≥ 1 cm by spiral CT scan

- Non-measurable (bone) disease consisting of ≥ 2 new areas of uptake by bone scan
consistent with metastatic disease compared to previous imaging during
castration therapy

- Ambiguous results must be confirmed by other imaging modalities (e.g.,
X-ray, CT scan, or MRI)

- Presence of visceral metastases

- No known brain metastases

- Life expectancy ≥ 18 months by Halabi nomogram

- ECOG performance status 0-2

- WBC ≥ 2,000/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 2.0 mg/dL

- AST and ALT ≤ 1.5 times upper limit of normal

- Total bilirubin normal

- Fertile patients must agree to use effective contraception before, during, and for ≥
4 months after completion of study therapy

- No known infection with HIV 1 or HIV 2, HTLV-1, hepatitis B, or hepatitis C, or any
other potentially immunosuppressive infection

- Patients must have negative serologic testing for HIV, hepatitis B surface
antigen, and hepatitis C

- No history of autoimmune disease requiring active immunosuppressive therapy or ≥
grade 2 organ dysfunction as a result of known autoimmune disease

- Patients must have antinuclear antibody (ANA) titer < 1:320

- No other active malignancy except nonmelanoma skin cancer, carcinoma in situ of the
bladder, or other adequately treated cancer that has been free of recurrence for ≥ 3

- No allergy to eggs

- No known intolerance or allergic reactions to docetaxel or compounds of similar
chemical or biologic composition

- No known history of allergic or intolerable reaction to vaccinia virus vaccination
(e.g., smallpox)

- Patients or close household contacts of patients cannot have close contact with
persons with the following conditions within 3 weeks after potential vaccinia

- History of eczema, active eczema or other acute, chronic, or exfoliative skin
conditions, including Darier's disease (e.g., atopic dermatitis, burns,
impetigo, varicella zoster, severe acne, or open wounds)

- Pregnant or nursing women

- Children under 3 years of age

- Immunodeficient or immunosuppressed persons (e.g., HIV infection, or treated for
other diseases with immunosuppressive agents)

- Any other moderate or severe acute illness until the illness resolves

- None of the following conditions within the past 6 months:

- Stroke

- Myocardial infarction

- Unstable angina

- NYHA class II-IV congestive heart failure

- Significant cardiomyopathy requiring treatment

- At least 4 weeks since prior nonsteroidal antiandrogen (e.g., flutamide) (6 weeks for
bicalutamide or nilutamide)

- More than 4 weeks since prior and no concurrent therapy with any of the following:

- Other systemic corticosteroids

- Inhaled, intranasal, or topical corticosteroids allowed

- No steroid eyedrops at least 2 weeks before and 4 weeks after protocol


- Saw palmetto

- Megestrol

- Ketoconazole

- 5-α-reductase inhibitors

- Patients on 5-α-reductase inhibitors for > 28 days may continue these
agents throughout the study

- May not start therapy with 5-α-reductase inhibitors during study therapy

- Diethyl stilbestrol

- Any other hormonal agent or supplement with possible anticancer activity

- More than 4 weeks since prior external-beam radiation therapy

- At least 4 weeks since any prior treatment and recovered

- More than 4 weeks since surgery

- More than 6 months since prior chemotherapy

- Prior and/or concurrent bisphosphonates allowed

- More than 2 weeks since prior and no concurrent CYP3A4 substrates, inhibitors, or

- No prior chemotherapy for metastatic prostate cancer

- No prior radiotherapy to > 30% of bone marrow

- No prior anticancer vaccine

- No prior splenectomy

- No other concurrent investigational agents or anticancer therapy other than
androgen-deprivation treatment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median overall survival

Outcome Description:

The method of Kaplan and Meier will be used to characterize overall survival, and the stratified log-rank test will be used to compare this endpoint between treatment arms.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Douglas McNeel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



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