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Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer



- Compare the rate of 3-year biochemical progression-free survival (bPFS) in patients
with high-risk, clinically localized prostate cancer treated with radical prostatectomy
with vs without neoadjuvant chemohormonal therapy comprising docetaxel and
androgen-deprivation therapy with leuprolide acetate or goserelin.


- Compare the 5-year bPFS rate, bPFS, disease progression, disease-free survival, and
overall survival of patients treated with these regimens.

- Determine the safety and tolerability of neoadjuvant docetaxel and androgen-deprivation
therapy in these patients.

- Compare the time to clinically apparent local disease recurrence and metastatic disease
in patients treated with these regimens.

- Compare pathologic tumor stage, frequency of lymph node metastases, and positive margin
rates in patients treated with these regimens.

- Determine if changes in serum testosterone levels will predict bPFS in these patients.

- Determine, prospectively, whether prostate-specific antigen doubling time is a
surrogate endpoint for time to clinical metastases and overall survival in these

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs
40-59.9% vs ≥ 60%) and androgen-deprivation therapy in the past 3 months (no vs yes).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive goserelin subcutaneously or leuprolide acetate intramuscularly
once every 4 or 12 weeks for 18-24 weeks (measured from the date of starting
docetaxel). They also receive docetaxel IV over 1 hour on day 1. Treatment with
docetaxel repeats every 3 weeks for up to 6 courses. Within 60 days after completion of
chemohormonal therapy, patients undergo radical prostatectomy with staging pelvic

- Arm II: Within 60 days after randomization, patients undergo radical prostatectomy with
staging pelvic lymphadenectomy.

After completion of study therapy, patients are followed at 1 and 3 months and then
periodically for up to 15 years.

PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- No small cell, neuroendocrine, or transitional cell carcinoma

- Clinically localized, stage T1-3a disease

- No radiographic evidence of metastatic disease*, as demonstrated by all of the

- No pelvic lymph nodes > 1.5 cm by CT scan or MRI of the abdomen and pelvis or
endorectal MRI of the pelvis

- A negative biopsy required for lymph node(s) that measure > 1.5 cm

- If > 1 lymph node is > 1.5 cm, the largest or most accessible node is

- Negative bone scan with plain films and/or MRI/CT scan confirmation, if
necessary NOTE: *Positive positron emission tomography scan and Prostascint
scans are not considered proof of metastatic disease

- Serum prostate-specific antigen level ≤ 100 ng/mL within the past 6 weeks

- Patients must have a known Gleason sum based on biopsy or TURP at study entry

- High-risk disease, meeting 1 of the following criteria:

- Probability of biochemical progression-free survival at 5 years after surgery <
60% by Kattan nomogram prediction

- Biopsy Gleason score 8 to 10

- Deemed an appropriate candidate for radical prostatectomy


- ECOG performance status 0-2

- Life expectancy > 10 years

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 150,000/mm^3

- Creatinine ≤ 2.0 mg/dL

- Bilirubin normal (≤ 2.5 times upper limit of normal [ULN] for patients with Gilbert's

- AST and ALT ≤ 1.5 times ULN

- Fertile patients must use effective contraception during and for ≥ 2 months after
completion of study treatment

- Not at high risk for cardiac complications

- Prior deep venous thrombosis, pulmonary embolism, and/or cerebrovascular
accident allowed


- No prior treatment for prostate cancer, including surgery, pelvic lymph node
dissection, radiotherapy, or chemotherapy

- Prior transurethral resection of prostate allowed

- Prior androgen-deprivation therapy (e.g., luteinizing hormone-releasing hormone
agonists, antiandrogens, or both) lasting ≤ 4 months allowed

- Concurrent systemic anticoagulation allowed

- No other concurrent systemic therapy, including androgen-deprivation therapy for the
treatment of the prostate cancer

- No concurrent oral antiandrogens

- No concurrent aprepitant

- No other concurrent chemotherapeutic agents except for any of the following:

- Steroids given for adrenal failure

- Hormones administered for nondisease-related conditions (e.g., insulin for

- Intermittent use of dexamethasone as an antiemetic or as pretreatment for
patients receiving docetaxel

Type of Study:


Study Design:

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

Outcome Measure:

3-year biochemical progression-free survival (bPFS) rate

Safety Issue:


Principal Investigator

James A. Eastham, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center



Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms



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