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New treatment option for Castration Resistant Prostate Cancer
Official title Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
ClinicalTrials.gov ID: NCT05919329
What this study is testing
What is Piflufolastat?
Piflufolastat is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for castration resistant prostate cancer.
Also referred to as Piflufolastat F-18, Pylarify.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions...
- 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:
You likely can't join if
- Uncontrolled serious infection.
- Intercurrent illness or condition that would limit compliance with study requirements.
- Participants who have undergone any cancer treatment other than the hormonal therapy (systemic or radiation therapy) or who have started any...
See the full eligibility 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...
- 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...
- Cohort 2: Castration sensitive prostate cancer with no ADT or AR targeted agents use in the past 12 months, testosterone \>50 ng/dL
- Uncontrolled serious infection.
- Intercurrent illness or condition that would limit compliance with study requirements.
- Participants who have undergone any cancer treatment other than the hormonal therapy (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the...
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.