Clinical Trials

Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

Location:

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

Primary

- 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.

Secondary

- 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 patients.

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 lymphadenectomy.

- 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.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- 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 following:

- 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 biopsied

- 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

PATIENT CHARACTERISTICS:

- 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 disease)

- 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

PRIOR CONCURRENT THERAPY:

- 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 diabetes)

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

Last updated: 02/19/2013

NCT ID:

NCT00430183