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Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

This study has been terminated.
(Lack of funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480857
First Posted: May 31, 2007
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Michigan Cancer Center
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Percentage of Patients Alive Without Progression at 4 Years [ Time Frame: 4 years ]
    The primary objective is 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:
  • Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less [ Time Frame: 4 years ]
    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.

  • The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities [ Time Frame: 4 years ]

    To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

    G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening


  • The Number of Patients That Experience Evidence of Local Recurrence [ Time Frame: 4 years ]
    The number of patients that have local disease recurrence by imaging and clinical findings.

  • The Number of Patients Alive [ Time Frame: 4 years ]
    The number of patients alive at 4 years.


Enrollment: 19
Study Start Date: March 2007
Study Completion Date: July 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel 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 (Prostate Specific Antigen) 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Performance Status: Karnofsky performance status ≥ 80% (Performance status is an attempt to quantify cancer patients' general well-being and activities of daily life. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.)
  • 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 (Computerized Tomography) 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 (Complete Blood Count)/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 (Alanine Transaminase), AST (Aspartate Aminotransferase), 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00480857     History of Changes
Other Study ID Numbers: UMCC 2006.066
HUM 7093 ( Other Identifier: University of Michigan Medical IRB )
First Submitted: May 29, 2007
First Posted: May 31, 2007
Results First Submitted: January 9, 2015
Results First Posted: January 16, 2015
Last Update Posted: October 6, 2017
Last Verified: September 2017

Keywords provided by University of Michigan Cancer Center:
Prostate
Radiation

Additional relevant MeSH terms:
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action