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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2018-07-12
NCT00567580Uploaded 05-07-2024
Access via NCI by Request
PDS UID: nci-data-543
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
Provider Information
Provider Data DescriptionNCT00567580-D1: This dataset, NCT00567580-D1, contains the patient characteristics, outcome, and toxicity data presented in the RTOG-0534 primary publication (PMID: 35569466). NCT00567580-D2 contains highest-grade adverse events. NCT00567580-D3 contains acute adverse events. NCT00567580-D4 contains late adverse events.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsProstate Cancer
Intervention TypeRadiation: PBRT
Radiation: PLNRT
Drug: AA
Drug: LHRH agonist
Drug(s)Drug: AA
Drug: LHRH agonist
Total Enrolled1792
RandomizationRandomized
Blinding MethodNone
Arms InterventionPBRT Alone - Active Comparator
PBRT + STAD - Experimental
PLNRT + PBRT + STADT - Experimental
Secondary IDCDR0000577574
PubMed (PMID)35569466
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
NRG Oncology
Region(s)United States
Canada
China
Israel
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00567580-D1
Data DictionaryNCT00567580-D1-Data-Dictionary_1.pdf
DATANCT00567580-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00567580-D2
Data DictionaryNCT00567580-D2-Data-Dictionary_1.pdf
DATANCT00567580-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00567580-D3
Data DictionaryNCT00567580-D3-Data-Dictionary_1.pdf
DATANCT00567580-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00567580-D4
Data DictionaryNCT00567580-D4-Data-Dictionary_1.pdf
DATANCT00567580-D4-Dataset.csv
OTHERREADME.pdf
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