Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00480857
First received: May 29, 2007
Last updated: May 11, 2013
Last verified: May 2013
  Purpose

The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer is radiation therapy alone, possibly in combination with hormonal therapy. In this study, all patients will receive chemotherapy and radiation therapy. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments. This study is to determine the effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment for recurrent prostate cancer after surgery.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel (Taxotere)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Progression free proportion of patients [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To evaluate the predictive and prognostic significance of selected tissue, serum and genomic biomarkers in protocol patients. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To determine the rates of complete biochemical response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

  • To determine the rates of acute and late toxicities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    To determine the rates of acute and late toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

  • To determine the rates of local recurrence-free survival, distant metastasis- free survival, disease-specific survival and overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To determine the rates of local recurrence-free survival, distant metastasis-free survival, disease-specific survival and overall survival after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.


Enrollment: 19
Study Start Date: March 2007
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel (Taxotere)
    Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Detailed Description:

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 prostatectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 follows:

    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480857

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5010
Sponsors and Collaborators
University of Michigan Cancer Center
Sanofi
Investigators
Principal Investigator: Daniel A. Hamstra, M.D., Ph.D. University of Michigan
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00480857     History of Changes
Other Study ID Numbers: UMCC 2006.066, HUM 7093
Study First Received: May 29, 2007
Last Updated: May 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
Prostate
Radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014