Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:6/10/2018
Start Date:December 2005

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A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using
drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer
by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays
to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. It is not yet known whether giving hormone therapy and radiation therapy
together with chemotherapy is more effective than giving hormone therapy together with
radiation therapy in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy
followed by docetaxel and prednisone to see how well it works compared to hormone therapy and
radiation therapy in treating patients with localized prostate cancer.

OBJECTIVES:

Primary

- Compare the relative efficacy, in terms of overall survival, of the combination of
androgen suppression and radiotherapy versus androgen suppression and radiotherapy
followed by docetaxel and prednisone in patients with localized, high-risk prostate
cancer.

Secondary

- Compare the disease-free survival and incidence of adverse events in patients treated
with these regimens.

- Compare the biochemical control, local control, and freedom from distant metastases in
patients treated with these regimens.

- Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a
surrogate for overall survival of patients treated with these regimens.

- Compare the time interval between biochemical failure and distant metastases with
respect to testosterone level in patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to risk group.

- Arm I: Patients receive androgen suppression therapy comprising luteinizing
hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin,
buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for
2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients
undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is
discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20
months.

- Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm
I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV
over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients continue LHRH agonist therapy as in arm I.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer at high-risk for recurrence within the past
180 days as determined by 1 of the following combinations (risk groups):

- Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage

- Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2

- Gleason score 8, PSA 20-150 ng/mL, and any T stage

- Gleason score 7, PSA 20-150 ng/mL, and any T stage

- Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal
sampling, or dissection within 90 days prior to study entry

- Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed

- Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a
corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed

- PSA ≤ 150 ng/mL

- Cannot have been obtained during any of the following time points:

- 10-day period after prostate biopsy

- After initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

- No distant metastases by physical exam and bone scan

- Equivocal bone scan findings allowed if plain films are negative

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,800/mm^3

- Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)

- Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper
limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Fertile patients must use effective contraception during and for at least 3 months
after completion of study treatment

- No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy,
unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or
bladder are allowed)

- No unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- No transmural myocardial infarction within the past 6 months

- No acute bacterial or fungal infection requiring intravenous antibiotics

- No AIDS

- No prior allergic reaction to any study drugs or other drugs formulated with
polysorbate 80

- No existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

- At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for
prostatic hypertrophy

- At least 90 days since prior testosterone

- Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen
ablation was initiated no more than 50 days prior to study entry

- No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral
orchiectomy

- No prior systemic chemotherapy for prostate cancer

- Prior chemotherapy for a different cancer is allowed

- No prior radiotherapy, including brachytherapy, to the region of prostate cancer that
would result in overlap of radiotherapy fields

- Intensity modulated radiotherapy allowed
We found this trial at
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185 Cambridge Street
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