Prostate Cancer
Conditions
Keywords
Prostate, Prostate Cancer, Androgen Deprivation Therapy, Posluma, Orgovyx, PSMA-PET
Brief summary
This is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. The intent of the study is to determine the effect of ADT on PSMA expression as measured by PSMA-PET scan. A second PSMA-PET scan will be performed after ADT for either 3 or 6 weeks, depending on cohort, prior to RALP and PLND.
Interventions
DIAGNOSTIC_TESTflotufolastat F 18
PSMA-PET scan with Posluma agent (x2)
DRUGRelugolix 120 MG
Administration of oral ADT for 3 and 6 weeks
DIAGNOSTIC_TESTSerum PSA and Testosterone
Serum PSA and testosterone at study initiation and again at 3 and 6 weeks after initiation of ADT
Sponsors
Blue Earth Diagnostics
Texas Health Resources
Urology Clinics of North Texas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Men diagnosed with unfavorable intermediate or high-risk prostate cancer where RALP and PLND is planned and consulted with primary urologist
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT | 3-6 weeks | Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: SUVmax will be measured on PSMA-PET for each lesion identified prior to ADT and again after 3 or 6 weeks of ADT (depending on cohort). The primary metric will be the mean change in SUVmax per lesion, per participant. Data will be summarized as mean ± SD, and analyzed using paired statistical testing to determine significance of change. |
| New lesions not identified pre-treatment are detectable after ADT | 3-6 weeks | Time Frame: Baseline and 3-6 weeks post-ADT initiation Description: PSMA-PET scans performed at 3 or 6 weeks after ADT will be compared to baseline scans to identify newly visible lesions. The outcome will be reported as the number and proportion of participants with new lesions. Descriptive statistics will be used to summarize findings. |
| Establish the optimal duration of ADT necessary to achieve castrate level of testosteroneTime to castration-level testosterone (≤50 ng/dL) following initiation of oral ADT (relugolix 120 mg daily) | 3-6 weeks | Time Frame: 0 to 6 weeks after initiation of ADT Description: Serum testosterone will be measured at baseline, 3 weeks, and 6 weeks. The time point at which testosterone ≤50 ng/dL is first achieved will be recorded for each participant. Data will be summarized by frequency, proportion, and median time to castration levels. |
| Proportion of lesions visible on baseline PSMA-PET that remain detectable on post-ADT PSMA-PET | 3-6 weeks | Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: Lesions identified at baseline will be matched to post-ADT PSMA-PET scans. The number and proportion of lesions that remain visible after ADT will be recorded. This will help assess whether ADT obscures PSMA-positive disease on imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PSMA-PET findings and surgical pathology | 3-6 weeks | Time Frame: Surgery performed 6-10 weeks after enrollment Description: Lesions identified by PSMA-PET will be compared to histopathologic findings from prostatectomy and pelvic lymph node dissection specimens. Correlation statistics (e.g., sensitivity, specificity, positive predictive value) will be calculated. |
| Concordance between study PSMA-PET and conventional imaging or alternative PSMA-PET agents (if available) | 3-6 weeks | Time Frame: 3-6 weeks after ADT, when comparator imaging is available Description: In participants who undergo additional imaging (e.g., bone scan, CT, or alternative PSMA-PET tracers), lesions will be compared to those seen on study PSMA-PET. Concordance will be reported as number and proportion of lesions detected by both modalities. |
Countries
United States
Outcome results
None listed