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Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy

There is no treatment proven more effective for clinically localized prostate cancer than
radical prostatectomy. Nonetheless, approximately 30,000 men annually in the U.S. develop
recurrence of their prostate cancer after prostatectomy. Radiation therapy is commonly
utilized as attempted salvage treatment for patients who develop a rising PSA after
prostatectomy and have no evidence of metastatic disease. This study is designed to
determine whether concurrent chemotherapy, weekly docetaxel, and daily radiation therapy
will result in improved disease control and survival rates over those obtained with
radiotherapy alone in the treatment of men with biochemical recurrence after radical

Inclusion Criteria:

- Age ≥ 18

- Performance Status: Karnofsky performance status ≥ 80%

- Has undergone prostatectomy for histologically confirmed adenocarcinoma of the
prostate at least 6 weeks prior to registration. (If prostatectomy was completed at
an outside facility, a University of Michigan pathology review must take place to
confirm adenocarcinoma.)

- Has biochemical evidence of failure as determined by at least two PSA measurements
after prostatectomy. This must be demonstrated by an increase of at least 0.1 ng/mL
between two consecutive measurements, both obtained after prostatectomy. The most
recent measurement (within 28 days of registration) must be 0.3 ng/mL or greater.

- Has undergone pelvic CT scan and radionuclide bone scan within 90 days prior to
registration that showed no evidence of regional or distant nodal or bone metastasis.

- Patients with pelvic or abdominal lymph nodes equivocal or questionable by imaging
are eligible if the nodes are < 1.5 cm in long axis.

- Equivocal bone scan findings are allowed if plain films show no conclusive evidence
of metastasis.

- Hematologic Criteria: CBC/differential obtained within 28 days prior to registration
on study, with adequate bone marrow function defined as follows:

- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

- Platelets ≥ 100,000 cells/mm3

- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to
achieve Hgb = 8.0 g/dl is acceptable).

- Hepatic Criteria within 28 days prior to registration:

- Total bilirubin < 1 x institutional upper limit of normal (ULN)

- ALT, AST, and alkaline phosphatase must be within the eligible ranges stipulated
in protocol table

- Serum creatinine < 2 x ULN

- Both radiation oncology and medical oncology consultation prior to registration.

- Pharmacologic androgen ablation for prostate cancer will be allowed only if given
prior to prostatectomy.

- Patient must sign study specific informed consent prior to study entry.

- Peripheral neuropathy: must be ≤ grade 1

- Patients must be willing to consent to using effective contraception while on
treatment and for at least 3 months thereafter.

Exclusion Criteria:

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80.

- Evidence of M1 metastatic disease

- Pathologically positive lymph nodes or nodes > 1.5 cm on imaging

- Prior pelvic radiotherapy that would result in overlap of radiation therapy fields or
systemic cytotoxic chemotherapy.

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 5 years (for example,carcinoma in situ of the oral cavity or bladder
are permissible)

- Severe, active co-morbidity, defined as follows, active co-morbidity, defined as

- Unstable angina and/or congestive heart failure requiring hospitalization within
the 6 months prior to registration.

- Transmural myocardial infarction within the 6 months prior to registration

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition;
note, however, that HIV testing is not required for entry into this protocol.
The need to exclude patients with AIDS from this protocol is necessary because
the treatments involved in this protocol may be significantly immunosuppressive.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free proportion of patients

Outcome Description:

To assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Daniel A. Hamstra, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2006.066



Start Date:

March 2007

Completion Date:

May 2014

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Radiation
  • Prostatic Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624