Radiation Therapy Approaches for People With Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-metastatic prostate cancer.
Classified as unfavorable intermediate-, high-, or very high-risk prostate cancer according to NCCN risk stratification guidelines. (Note: cT3a or T3b by MRI or PSMA PET allowed)
Considered by the treating radiation oncologist as a suitable candidate for both HDR brachytherapy boost and SBRT
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care HDR Brachytherapy
RadiationHDR Brachytherapy
SBRT
RadiationSBRT alone
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Arm A: HDR Brachytherapy Boost + SBRTActive comparator 2 interventions
Group B: Arm B: SBRT AloneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in International Prostate Symptom Score / IPSS at 3 months
Change in International Prostate Symptom Score / IPSS to measure if SBRT alone results in less acute patient reported urinary symptoms measured by IPSS at 3 months than HDR brachytherapy boost combined with SBRT
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Palette Life Sciences, Inc.
Collaborator
Source ClinicalTrials.gov