James Eastham, MD, Memorial Sloan Kettering Cancer Center
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Drug: LHRH agonist
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as
goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving
docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce
the amount of normal tissue that needs to be removed. It is not yet known whether giving
docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in
treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin
to see how well they work when given before surgery compared with surgery alone in treating
patients with high-risk localized prostate cancer.
Ages Eligible: 18 Years
Accepts Healthy Volunteers:
1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma.
Patients with small cell, neuroendocrine, or transitional cell carcinomas are not
All eligible patients must have a known Gleason sum based on biopsy or TURP at the
time of registration.
2. Clinically localized disease - Patients must have clinical stage T1-T3a and no
radiographic evidence of metastatic disease as demonstrated by:
- EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that
demonstrate no nodes > 1.5 cm. If one or more pelvic lymph node(s) measures >
1.5 cm, a negative biopsy is required. If more than one lymph node is > 1.5 cm,
the largest or most accessible node should be biopsied.
- Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if
necessary). Positive PET and Prostascint scans are not considered proof of
3. Determination of high-risk status: Patients must have either:
- A Kattan nomogram predicted probability of being free from biochemical
progression at 5 years after surgery of < 60%.
- Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be
calculated for all patients, including those eligible based on Gleason sum ≥ 8
4. Prior treatment - No prior treatment for prostate cancer including prior surgery
(excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.
Patients may have received up to 4 months of androgen deprivation therapy (LHRH
agonists, antiandrogens, or both) prior to being enrolled on the study.
5. Appropriate surgical candidates - Patients must be appropriate candidates for radical
prostatectomy with an estimated life expectancy > 10 years as determined by a
urologist. Evidence of underlying cardiac disease should be evaluated prior to
enrollment to ensure that patients are not at high risk of cardiac complications.
6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary
embolism, and/or cerebrovascular accident or currently requiring systemic
anticoagulation are eligible provided they are determined to be candidates for
7. ECOG performance status: 0-2
8. Age: ≥ 18 years of age
9. Required Initial Laboratory Values:
- ANC ≥ 1500/μL
- Platelet count ≥ 150,000/μL
- Creatinine ≤ 2.0 mg/dL
- Pre-registration serum PSA level ≤ 100 ng/mL
- Bilirubin ≤ 1.5XULN (2.5XULN
in patients with Gilbert's disease)
- AST/ALT ≤1.5XULN
James Eastham, MD
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Information obtained from ClinicalTrials.gov, on
7/4/2015. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: