A Study of Lower Dose Radiation Therapy for People With Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to see whether giving a lower (de-escalated) dose of radiation therapy to some parts of the prostate can reduce side effects compared to giving the same (uniform) dose of radiation therapy to the whole prostate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documentation of Disease
Definition of Disease
Grade Group (GG) 1, 2, or 3.
PSA less than 20 ng/mL prior to starting ADT, if used.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
MR-guided Stereotactic Body Radiation Therapy
RadiationMR-guided 2 fraction Stereotactic Body Radiation Therapy
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Group 1: Uniform dose SBRTActive comparator 1 intervention
Group B: Group 2: De-escalated dose SBRTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with acute GU toxicities
To estimate the absolute and relative risk of acute GU toxicity (CTCAE v5) when delivering dose de-escalated or uniform dose prostate SBRT, both using a 2-fraction regimen.
Time frame
12 weeks from the start of radiation therapySponsors and contacts
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Source ClinicalTrials.gov