Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Brief summary
The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy. The names of the treatment interventions involved in this study are: * Androgen receptor antagonist monotherapy. * PSMA PET/CT scan It is expected that about 15 people will take part in this research study. Participation in this research study is expected to last about 4 weeks.
Detailed description
This research study is a pilot study, and it is the first time investigators are directly examining the effect of standard androgen receptor antagonists on Prostate-Specific Membrane Antigen (PSMA) expression for participants with recurrent, asymptomatic, metastatic hormone-sensitive prostate cancer (mHSPC). This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy. The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, and follow up visits. The names of the treatment interventions involved in this study are: * Androgen receptor antagonist monotherapy. * PSMA PET/CT scan The U.S. Food and Drug Administration (FDA) has approved apalutamide, darolutamide, and enzalutamide for the treatment of prostate cancer. It is expected that about 15 people will take part in this research study. Participation in this research study is expected to last about 4 weeks. Funding for this research study is provided by a philanthropic gift.
Interventions
DRUGApalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]
per standard care
DIAGNOSTIC_TESTProstate-Specific Membrane Antigen (PSMA) PET/CT Scan
Per standard care
Sponsors
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age 40 or higher with prostate cancer that has been previously treated with primary definitive local therapies (prostatectomy with or without salvage radiation, or primary prostate radiation) and subsequently experiencing rising PSA meeting criteria for biochemical failure (PSA \>0.2 ng/dL x2 following prostatectomy, or PSA \> 2 + nadir value following primary radiation). * PSMA PET/CT (Ga68, piflutolastat F-18, or other FDA-approved tracer) during time of biochemical recurrence, and within 6 weeks of registration, showing at least one lesion suspicious for recurrent prostate cancer based on size and/or SUV. * Testosterone \>100 ng/dL within 6 months prior to enrollment with no intervening hormonal therapies. * Assigned by treating physician to receive standard-of-care AR antagonist monotherapy, using FDA-approved apalutamide, darolutamide, or enzalutamide.
Exclusion criteria
* High disease burden, significant symptoms of disease, or other clinical situation requiring medical/surgical castration and/or docetaxel during the time of the study. * Not suitable for AR antagonist therapy (e.g. inability to swallow pills, poor adherence, advanced liver disease, prohibitive co-payment without available patient assistance funding, contraindicated drug-drug interaction). * Older-generation AR antagonists (e.g. bicalutamide) are not allowed on study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with New Lesions (Flare) | week 1 | Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tumor size | week 1 | Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean. |
| Changes in tumor SUV | week 1 | For up to 5 target lesions. Standardized Uptake Value Max and Mean. |
| Changes in serum PSA | week 1 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Einstein, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed