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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of prostate-specific antigen (PSA) decline and the number of subjects reaching a PSA nadir of zero following the intervention.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Gregory P. Swanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Federal Government

Study ID:

CDR0000486733

NCT ID:

NCT00348816

Start Date:

May 2006

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811