Clinical Trials

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Prostate Cancer Clinical Trials

Radiation Therapy vs. Androgen Deprivation
A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy (RTOG 0534)
Status Conditions Phase Study ID
Recruiting Prostate Cancer Phase III RTOG 0534
NCT00567580
Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer.

PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.


Investigator
George Laramore, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Adenocarcinoma of the prostate treated primarily with radical prostatectomy

    • Pathologically proven to be lymph node-negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (Nx [undissected pelvic lymph nodes because lymph node dissection is not required])
    • Any type of radical prostatectomy allowed, including retropubic, perineal, laparoscopic or robotically assisted
    • Meets 1 of the following pathologic classifications:

      • T3 N0/Nx disease
      • T2 N0/Nx disease with or without positive prostatectomy margins
    • N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is negative
    • Prostatectomy Gleason score of 8 or less
  • A post-radical prostatectomy entry PSA of ≥ 0.1 and ≤ 1.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration
  • Serum total testosterone ≥ 40% of the lower limit of normal (patients who have had a unilateral orchiectomy are eligible as long as this requirement is met)
  • No distant metastases based on history/physical examination, CT scan or MRI of the abdomen and pelvis, and bone scan
  • No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Platelets ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve this is allowed)
  • AST or ALT < 2 x upper limit of normal
  • No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for a minimum of 5 years (e.g., carcinoma in situ of the oral cavity is permissible)
  • No severe, active co-morbidity, including any of the following:

    • History of inflammatory bowel disease
    • History of hepatitis B or C
    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition

      • HIV testing is not required for entry
  • No prior allergic reaction to the study drug(s) involved in this protocol

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No androgen deprivation therapy started prior to prostatectomy for > 6 months duration
  • No androgen deprivation therapy started after prostatectomy and prior to registration
  • No prior pelvic radiotherapy
Last Updated
March 21, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.