Clinical trial NCT00348816: Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2006-07-06
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free Survival Based on PSA Progression
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
measure: Correlation Between Velocity of Subsequent PSA Failure and Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Gregory P. Swanson, MD
role: STUDY_CHAIR
References: