NCT05852041ToborozKorai 1. fázis
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 2.
Rövid összefoglaló (regiszter, angolul)
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. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2023. máj. 1.
- Kezdés
- 2023. jún. 7.
- Elsődleges befejezés
- 2026. máj. 13.
- Fő szponzor
- Northwestern University
- Betegségek
- Prosztatarák
- NCT-szám
- NCT05852041
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · Korai 1. fázis
- Tervezett résztvevők: 40
- 2023. jún. 7. és az elsődleges befejezés (2026. máj. 13.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
- 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
- Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening
Más betegség
- 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)
- History of hip replacement
Egyéb
- Decipher score < 0.45
- Contra-indication or relative contra-indication to MRI (i.e., pacemaker)
Kiket keres a vizsgálat
- 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 [Gleason 3+3=6] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 [Gleason score 3+4=7])
- 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 representative prior to any study-related procedures
- 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
Életkor a regiszterben: 18 év – - · Nem: csak férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Northwestern University | Chicago | Egyesült Államok | Toboroz |
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