Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.

Detailed Description
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OBJECTIVES: Primary Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy. Secondary Determine the tolerability of this regimen in these patients. Determine the progression-free survival, based on PSA progression, of these patients. Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy. Determine if the velocity of subsequent PSA failure impacts survival of these patients. Tertiary Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy. Quaternary: To collect data on a contemporary cohort to those on study that received radiation alone. We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes. OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
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A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: prednisone
* Procedure: Radical prostatectomy
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed prostate cancer Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago No lymph node-positive prostate cancer No documented metastatic disease CT scan of the abdomen and pelvis negative (within the past 6 months) No bone pain OR negative bone scan (within the past 6 months) ECOG performance status 0-2 Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL Bilirubin normal ALT and AST ≤ 1.5 times upper limit of normal Alkaline phosphatase normal Fertile patients must use effective contraception No peripheral neuropathy > grade 1 No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer No serious illness with a life expectancy of < 5 years No concurrent medical, psychological, or social circumstance that would preclude study compliance No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 Exclusion Criteria: No prior orchiectomy No prior chemotherapy regimen for this disease No prior pelvic radiotherapy No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride Preoperative androgen manipulation for a duration of ≤ 3 months allowed No prior immunotherapy No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) No concurrent herbal or alternative regimens including, but not limited to, any of the following: Saw palmetto PC-SPES Shark cartilage No other concurrent investigational agents No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel (Single Arm)<br>Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel | Drug: docetaxel<br>* Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.<br>* Other names: Taxotere;Drug: prednisone<br>* Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.<br>* Other names: prednisone oral;Procedure: Radical prostatectomy<br>* Radical prostatectomy as part of standard care<br>Radiation: Radiation therapy<br>* Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention. | Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero.. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival Based on PSA Progression | Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up. | 5 years | 
| Overall Survival |  | 5 years | 
| Correlation Between Velocity of Subsequent PSA Failure and Survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer