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New treatment option for Prostate Adenocarcinoma
Official title rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
ClinicalTrials.gov ID: NCT05852041
What this study is testing
What is Decipher Prostate Cancer Test?
Decipher Prostate Cancer Test is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate adenocarcinoma.
Also referred to as Decipher, Decipher Metastasis Test.
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 evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning.
- Phase 1: an early, usually small safety study
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. Healthy volunteers may be eligible.
You may be able to join if
- Healthy men (Eastern Cooperative Oncology Group [ECOG] 0-1), \>= 18 years old with at least 10 year life expectancy
- Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate
- Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \>= 10 core biopsy and informed...
- Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a...
- Decipher genomic classifier score from prior biopsy \>= 0.45
You likely can't join if
- Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
- NCCN very low risk category (T1c and Gleason Grade Group 1 [Gleason score 3+3=6], PSA \< 10 ng/mL, fewer than 3 prostate biopsy cores positive, =\<...
- Decipher score \< 0.45
- Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], Urolift...
- Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening
- Contra-indication or relative contra-indication to MRI (i.e., pacemaker)
See the full eligibility criteria
- Healthy men (Eastern Cooperative Oncology Group [ECOG] 0-1), \>= 18 years old with at least 10 year life expectancy
- Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate
- Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \>= 10 core biopsy and informed by prior mpMRI
- Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen [PSA] \< 10ng/ml, Gleason Grade Group 1...
- Decipher genomic classifier score from prior biopsy \>= 0.45
- Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized...
- Concurrent diseases and malignancies are permitted
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
- Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging
- Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
- NCCN very low risk category (T1c and Gleason Grade Group 1 [Gleason score 3+3=6], PSA \< 10 ng/mL, fewer than 3 prostate biopsy cores positive, =\< 50% cancer in any core, PSA density \< 0.15 ng/mL/g)
- Decipher score \< 0.45
- Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], Urolift, Rezum)
- Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening
- Contra-indication or relative contra-indication to MRI (i.e., pacemaker)
- History of hip replacement
- Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, 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.