Active, currently enrolling
NRG-GU013: The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer
NCT No.: NCT05946213
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym:
Official Title
NRG-GU013: The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer
Purpose
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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• Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
• High-risk disease defined as having at least one or more of the following:
• cT3a-T3b by digital exam or imaging (American Joint Committee
on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on
digital rectal exam is not allowed
• The patient's prostate specific antigen (PSA) value > 20 ng/mL
prior to starting androgen deprivation therapy (ADT) Note:
Patients taking a 5-alpha reductase inhibitor (ex finasteride or
dutasteride) are eligible The baseline PSA value should be
doubled for PSAs taken while on 5-alpha reductase inhibitors
• Gleason Score of 8-10
• Pelvic node positive by conventional imaging with a short axis of
at least 1.0 cm
• Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan
• Age >= 18
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH] agonist and oral anti-androgen) is =< 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease
• Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
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Exclusion Criteria
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• No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• No prior radical prostatectomy
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Keywords and/or Specific Medical Conditions
Sponsors
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