Androgen-responsive POSLUMA-guided Intra-prostatic Boost
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMartin T. King, MD, PhD
About this trial
This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age and older.
Eastern Oncology Group Status 0 to 1.
Histologic diagnosis of prostate cancer.
Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
Disqualifiers
Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
Clinical T4 disease.
Prior ADT.
Trial design
Design model
Single group
Treatments tested in this trial
PSMA PET/CT
Diagnostic testPSMA PET/CT is an imaging test that uses a radioactive tracer to highlight prostate cancer cells. Imaging will be performed at baseline, approximately eight weeks after starting ADT, and approximately 24 weeks after starting ADT (end of treatment). These scans are used to guide radiation treatment planning and assess treatment response.
Androgen Deprivation Therapy (ADT) +/- bicalutamide
DrugADT is used to lower testosterone levels, which can slow or shrink prostate tumors. All participants will receive approximately six months of ADT starting before radiation therapy, using injectable or oral medications. Depending on the type of ADT, participants may also receive daily bicalutamide. Bicalutamide is categorized as an antiandrogen, which means it will block the effects of testosterone and work together with ADT to slow down or shrink prostate cancer.
Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost
RadiationSBRT is a form of radiation therapy that delivers precise, high-dose radiation to the prostate over a short period of time. SBRT will be initiated 10 weeks after initiation of ADT and will be delivered in five sessions over two weeks. Based on PSMA PET/CT and MRI findings after initiation of ADT, some participants may receive an optional focal radiation microboost to areas of residual cancer. The microboost, if delivered, will be given during the same SBRT treatment sessions and will be limited by standard safety constraints.
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: ADT + SBRT + PSMA PET/CT ImagingExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.
To evaluate whether \>50% of patients will be treated utilizing GTV contours that are highly concordant with those from interim PET/MR scans (GTV-combined-interim) based on the dice coefficient
Time frame
8 weeks from initiation of hormone therapy/before start of radiation therapySecondary outcomes
1
Geometric accuracies of GTV-Combined-Baseline and GTV-combined-interim contours
The Dice coefficient of GTV-Combined-Baseline contours by the treating physician versus those independently drawn by the principal investigator will be calculated. The Dice coefficient of GTV-Combined-Interim contours by the treating physician versus those independently drawn by the principal investigator will also be calculated.
Time frame
8 weeks from initiation of hormone therapy/before start of radiation therapy2
PSA response
The median PSA values at 8-weeks and 24-weeks will be evaluated. The percentage of patients with a PSA≥0.1 ng/mL will be calculated.
Time frame
8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)3
PSMA PET response
PSMA-PET/CT response at 8-weeks and 24-weeks will be characterized utilizing PSMA PET RECIP 1.0 criteria. * Complete response: Absence of any PSMA uptake at interim PET. * Partial: 30% or greater decrease in PSMA-avid total tumor volume. * Progression: 20% or greater increase in total tumor volume. New PSMA-avid lesions will also count as progression. * Stable disease: Less than 30% decrease or less than 20% increase in total tumor volume.
Time frame
8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)4
MRI ADC contrast ratio
The ADC contrast ratio at baseline and 8-weeks will be calculated by evaluating the ratio of the mean ADC contrast within GTV-MRI against ADC contrast within a surrounding 2 mm ring.
Time frame
8 weeks from initiation of hormone therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Martin T. King, MD, PhD
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Blue Earth Diagnostics
Collaborator
Dana-Farber/Brigham and Women's Cancer Center
Collaborator
Source ClinicalTrials.gov