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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

Description

Detailed Description
OBJECTIVES: Primary - To determine whether the addition of short-term androgen deprivation (STAD) to prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical failure, and absence of death from any cause) for 5 years, over that of PBRT alone in men treated with salvage radiotherapy after radical prostatectomy. - To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy after radical prostatectomy. Secondary - To compare the rates of a PSA ≥ 0.4 ng/mL and rising at 5 years after randomization (secondary biochemical failure endpoint), the development of hormone-refractory disease (3 rises in PSA during treatment with salvage androgen-deprivation therapy), distant metastasis, cause-specific mortality, and overall mortality. - To compare acute and late morbidity based on Common Toxicity Criteria for Adverse Effects (CTCAE), v. 3.0. - To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related genes in archival diagnostic tissue to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used. - To quantify blood product-based proteomic and genomic (single nucleotide polymorphisms) patterns and urine-based genomic patterns before and at different times after treatment to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used. - To assess the degree, duration, and significant differences of disease-specific health-related quality of life (HRQOL) decrements among treatment arms. - To assess whether mood is improved and depression is decreased with the more aggressive therapy if it improves FFP. - To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells for future translational research analyses. Tertiary - To assess whether an incremental gain in FFP and survival with more aggressive therapy outweighs decrements in the primary generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression). - To evaluate the cost-utility of the treatment arm demonstrating the most significant benefit (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies. - To assess associations between serum levels of beta-amyloid and measures of cognition and mood and depression. - An exploratory aim is to assess the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading system. OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no), prostatectomy Gleason score (≤ 7 vs 8-9), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs > 1.0 and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others). Patients are randomized to 1 of 3 treatment arms. - Arm I (prostate bed radiotherapy [PBRT] alone): Patients undergo PBRT once daily, 5 days a week, Monday through Friday, for approximately 7-8 weeks (36 to 39 fractions). - Arm II (PBRT and short-term androgen-deprivation [STAD]): Beginning 2 months before the start of PBRT, patients undergo STAD, using a combination of antiandrogen and luteinizing hormone-releasing hormone (LHRH) agonist therapy, for a total of 4-6 months. Patients receive antiandrogen therapy comprising either oral flutamide 3 times daily or oral bicalutamide once daily for at least 4 months (started within 1-14 days prior to the LHRH agonist and ending the last day of radiotherapy ± 14 days). Patients receive LHRH agonist injection beginning concurrently with or 2 weeks after the start of antiandrogen therapy. LHRH agonist injection consists of analogs approved by the FDA (or by Health Canada for Canadian institutions) (e.g., leuprolide, goserelin, buserelin, or triptorelin) and may be given in any possible combination (may be given as a single 4-month injection and one to two 1-month injection[s], two 3-month injections, or a 6-month injection), such that the total LHRH agonist treatment time is 4-6 months. Approximately 2 months after beginning of STAD, patients undergo PBRT as in arm I. - Arm III (Pelvic lymph node radiotherapy [PLNRT], PBRT, and STAD): Beginning 2 months before the start of radiotherapy, patients receive STAD therapy as in arm II. Approximately 2 months after beginning of STAD, patients undergo PBRT and PLNRT once daily, 5 days a week, Monday through Friday, for approximately 5 weeks (25 fractions) followed by PBRT only once daily, 5 days a week for approximately 2-3 weeks (11-14 fractions). Patients complete the American Urological Association Symptom Index (AUA SI) questionnaire prior to protocol treatment, at week 6 of radiotherapy, and then periodically after completion of study therapy. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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 with or without positive prostatectomy margins
  • 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 9 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)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit of normal
  • No prior invasive malignancy (except nonmelanoma skin cancer) or superficial bladder 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 Centers for Disease Control (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
  • More than 5 years since prior chemotherapy for any other disease site
  • No androgen-deprivation therapy started prior to prostatectomy for > 6 months duration
  • The use of finasteride or dutasteride (

Sites

  • California

    • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048
    • Veterans Affairs Medical Center - Long Beach, Long Beach, California, 90822
    • St. Joseph Hospital Regional Cancer Center - Orange, Orange, California, 92868
    • California Cancer Center - Woodward Park Office, Fresno, California, 93720
    • Cancer Care Associates, Fresno, California, 93720
    • Radiation Oncology Centers - Cameron Park, Cameron Park, California, 95682
    • Mercy General Hospital, Sacramento, California, 95819
    • Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, 95608
    • Solano Radiation Oncology Center, Vacaville, California, 95687
    • Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, 95815
    • Radiation Oncology Center - Roseville, Roseville, California, 95661
    • Auburn Radiation Oncology, Auburn, California, 95603
    • Saint Helena Hospital, Saint Helena, California, 94574

  • Utah

    • Dixie Regional Medical Center - East Campus, Saint George, Utah, 84770
    • Sandra L. Maxwell Cancer Center, Cedar City, Utah, 84720
    • Utah Valley Regional Medical Center - Provo, Provo, Utah, 84604
    • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, 84157
    • Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, 84106
    • LDS Hospital, Salt Lake City, Utah, 84143
    • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, 84403
    • Logan Regional Hospital, Logan, Utah, 84321

  • Arizona

    • Arizona Center for Cancer Care - Peoria, Peoria, Arizona, 85381
    • Arizona Oncology Services Foundation, Phoenix, Arizona, 85013
    • Arizona Oncology - Tucson, Tucson, Arizona, 85704

  • Oregon

    • Providence Cancer Center at PMCC, Medford, Oregon, 97504
    • Dubs Cancer Center at Rogue Valley Medical Center, Medford, Oregon, 97504
    • Three Rivers Community Hospital, Grants Pass, Oregon, 97527
    • Willamette Valley Cancer Center - Eugene, Eugene, Oregon, 97401

  • New Mexico

    • New Mexico Cancer Center, Albuquerque, New Mexico, 87109
    • University of New Mexico Cancer Center - South, Las Cruces, New Mexico, 88011

  • Washington

    • Legacy Salmon Creek Medical Center, Vancouver, Washington, 98686
    • CCOP - Virginia Mason Research Center, Seattle, Washington, 98101
    • Virginia Mason Medical Center, Seattle, Washington, 98101
    • St. Joseph Cancer Center, Bellingham, Washington, 98225

  • Texas

    • Texas Oncology, PA - Wichita Falls, Wichita Falls, Texas, 76310
    • Cancer Care Centers of South Texas - Northeast, San Antonio, Texas, 78217
    • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital, Fort Worth, Texas, 76104
    • Texas Oncology, PA at Texas Cancer Center - Denton South, Denton, Texas, 76210
    • Texas Oncology, PA at Harris Center HEB, Bedford, Texas, 76022
    • Texas Oncology, PA at Lake Vista Cancer Center, Lewisville, Texas, 75067
    • Texas Oncology, PA at Texas Cancer Center - Sherman, Sherman, Texas, 75090
    • Tyler Cancer Center, Tyler, Texas, 75702
    • Longview Cancer Center, Longview, Texas, 75601
    • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land, Sugar Land, Texas, 77479
    • Memorial Hermann Hospital - Memorial City, Houston, Texas, 77024

  • Kansas

    • Wesley Medical Center, Wichita, Kansas, 67214

  • Oklahoma

    • Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, 74136

  • Nebraska

    • Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, 68510
    • Nebraska Medical Center, Omaha, Nebraska, 68198

  • Minnesota

    • Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, 56201
    • Immanuel St. Joseph's, Mankato, Minnesota, 56002
    • Ridgeview Medical Center, Waconia, Minnesota, 55387
    • St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, 55379
    • Fairview Ridges Hospital, Burnsville, Minnesota, 55337
    • CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416
    • Park Nicollet Cancer Center, Saint Louis Park, Minnesota, 55416
    • Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, 55433
    • Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, 55432
    • United Hospital, Saint Paul, Minnesota, 55102
    • Minnesota Oncology - Maplewood, Maplewood, Minnesota, 55109
    • HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, 55109
    • Minnesota Oncology - Woodbury, Woodbury, Minnesota, 55125
    • St. Luke's Hospital Cancer Care Center, Duluth, Minnesota, 55805

  • Missouri

    • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters, Saint Peters, Missouri, 63376
    • Barnes-Jewish West County Hospital, Saint Louis, Missouri, 63141
    • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, 63110
    • Cancer Institute of Cape Girardeau, LLC, Cape Girardeau, Missouri, 63703

  • Wisconsin

    • Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin, 54601
    • Riverview UW Cancer Center at Riverview Hospital, Wisconsin Rapids, Wisconsin, 54494
    • Beloit Memorial Hospital, Beloit, Wisconsin, 53511
    • Aurora Medical Center, Summit, Wisconsin, 53066
    • Langlade Memorial Hospital, Antigo, Wisconsin, 54409
    • D.N. Greenwald Center, Mukwonago, Wisconsin, 53149
    • Central Wisconsin Cancer Program at Agnesian HealthCare, Fond du Lac, Wisconsin, 54935
    • Community Memorial Hospital Cancer Care Center, Menomonee Falls, Wisconsin, 53051
    • West Allis Memorial Hospital, West Allis, Wisconsin, 53227
    • Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, 53097
    • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, 53215
    • All Saints Cancer Center at Wheaton Franciscan Healthcare, Racine, Wisconsin, 53405
    • Columbia-Saint Mary's Water Tower Medical Commons, Milwaukee, Wisconsin, 53211
    • Bellin Memorial Hospital, Green Bay, Wisconsin, 54301
    • Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, 53295

  • Illinois

    • Leonard C. Ferguson Cancer Center, Freeport, Illinois, 61032
    • Mount Sinai Hospital Medical Center, Chicago, Illinois, 60608

  • Louisiana

    • CCOP - Ochsner, New Orleans, Louisiana, 70121

  • Indiana

    • Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, 46350
    • Howard Community Hospital, Kokomo, Indiana, 46904
    • CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601
    • Elkhart General Hospital, Elkhart, Indiana, 46515
    • Radiation Oncology Associates Southwest, Fort Wayne, Indiana, 46804
    • Parkview Regional Cancer Center at Parkview Health, Fort Wayne, Indiana, 46805

  • Michigan

    • Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, 49085
    • Foote Memorial Hospital, Jackson, Michigan, 49201

  • Kentucky

    • Norton Suburban Hospital, Louisville, Kentucky, 40207

  • Georgia

    • Piedmont Fayette Hospital, Fayetteville, Georgia, 30214
    • Piedmont Hospital, Atlanta, Georgia, 30309
    • Emory Crawford Long Hospital, Atlanta, Georgia, 30308
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