Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy (NCT05919329) | Clinical Trial Compass
RecruitingPhase 4
Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
United States80 participantsStarted 2024-06-25
Plain-language summary
This clinical trial investigates the change in prostate-specific membrane antigen (PSMA) expression in response to hormonal therapy in both, Castration Sensitive Prostate Cancer (CSPC) and Castration Resistant Prostate Cancer (CRPC), and whether this change in PSMA expression changes tumor staging after therapy initiation. Understanding these effects can help define the best timing to perform the PSMA positron emission tomography (PET) relative to the start of therapy.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
* Participants must have confirmed prostate adenocarcinoma, histologically, or by combined imaging and biochemical markers.
* Age \>= 18 years. Given the nature of the disease in question, only men will be included. Members of all races and ethnic groups will be included.
* Participants must have sites of prostate cancer showing uptake on an initial PSMA PET scan.
* Participants are planned to receive hormonal therapy within eight weeks of the initial PSMA PET. The hormonal therapy agents include:
* For CSPC: GnRH agonists, GnRH antagonists, first-generation antiandrogen (e.g. bicalutamide), or androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
* For CRPC: this group of patients are typically on continuous ADT (GnRH agonists or antagonists), which will be continued, and the hormonal therapy they will be started on is an androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
* Life expectancy \> 3 months.
* Cohort 1: Castration resistant prostate cancer with rising PSA (confirmed by two PSA values at least 1 week apart), testosterone \< 50 ng/dL, on continuous ADT at least 4 months, no AR targeted agent in the prior 4 months.
* Cohort 2: Castration sensitive prostate cancer with no ADT or AR targeted a…
What they're measuring
1
Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.
Timeframe: Baseline PSMA PET up to 8 days after therapy initiation