Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorNRG Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Bone Scan
Procedure/SurgeryUndergo bone scan
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
External Beam Radiation Therapy
RadiationUndergo EBRT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Treatment groups
1,209 Participants
are divided into 2 treatment groupsGroup A: Arm I (SBRT)Experimental treatment 8 interventions
Group B: Arm II (EBRT)Active comparator 7 interventions
Trial outcomes
Primary outcomes
1
Metastasis-free survival (MFS)
Based on conventional imaging. Median MFS time comparing the curves.
Time frame
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 yearsSecondary outcomes
1
Failure-free survival
Median failure-free survival time comparing the curves.
Time frame
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years2
Overall survival
Median survival time comparing the curves.
Time frame
From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 15 years3
MFS
Median MFS time comparing the curves.
Time frame
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years4
Incidence of adverse events (AEs)
AEs will be graded using National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Counts of all AEs by grade will be provided by treatment arm.
Time frame
Up to 15 yearsOther outcomes
1
Patient-reported outcomes
The EPIC-26 sexual domain will be assessed as an exploratory endpoint but following the analysis plan specified for the EPIC-26 urinary and bowel domains.
Time frame
Up to 5 years2
Cost
Measured by the Functional Assessment of Chronic Illness Therapy-COST.
Time frame
Up to 1 year3
Estimate of treatment effect by sex
Will estimate the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex.
Time frame
Up to 15 years4
Estimate of treatment effect by race
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by race.
Time frame
Up to 15 yearsSponsors and contacts
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Source ClinicalTrials.gov