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PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

StatusRecruiting
PhasePhase 2/3
Started2019-12-18
View on ClinicalTrials.gov ↗

Amendment history

2026-02-26
Study Status v27
Primary completion date2029-05→2029-02
2025-12-08
5 amendments v22-v26
5 re-verifications since 2024-11-07, no change to tracked fields
2024-06-05
Study Status v21
Primary completion date2024-06→2029-05
Completion date2024-06→2029-05
2023-12-01
3 amendments v18-v20
3 re-verifications since 2023-10-18, no change to tracked fields
2023-06-30
Study Status v17
Primary completion date2023-06→2024-06
Show 16 earlier versions
2023-01-24
2 amendments v15-v16
2 re-verifications since 2022-08-18, no change to tracked fields
2022-03-22
Study Status v14
Primary completion date2022-06→2023-06
Completion date2023-06→2024-06
2021-10-07
Study Status v13
Re-verified, no change to tracked fields
2021-07-26
Suspended→Recruiting Study Status, Contacts/Locations v12
Trial statusSuspended→Recruiting
Reason stoppedCompounding facility to submit quality update before they can manufacture 18F-DCFPyL→not stated
Study sitesdetails revised at 1 of 1 site
2021-05-13
Study Status v11
Re-verified, no change to tracked fields
2021-04-02
Study Status v10
Start date2019-10-17→2019-12-18
2020-11-02
Study Status v9
Re-verified, no change to tracked fields
2020-05-22
Recruiting→Suspended Study Status, Contacts/Locations v8
Trial statusRecruiting→Suspended
Reason stoppednot stated→Compounding facility to submit quality update before they can manufacture 18F-DCFPyL
Study sitesdetails revised at 1 of 1 site
2019-12-03
Study Status, Eligibility v7
Eligibility criteria-262 characters
[...] androgen deprivation therapy (ADT)) with ≥2 years follow up Normal renal function defined as serum creatinine of ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula). Male creatinine clearance = (140 - age in years) x weight in kg x 1.0072 x serum creatinine in mg/dL Age > 18 Exclusion Criteria: No follow up information availa [...]
2019-10-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-11→confirmed 2019-10-17
Study sitesdetails revised at 1 of 1 site
2019-08-06
Study Status v5
Start date2019-09→2019-11
2019-07-09
Study Status v4
Start date2019-06→2019-09
2019-03-21
Study Status v3
Start date2019-02→2019-06
2018-11-05
Study Status v2
Start date2018-10→2019-02
2018-06-25
Study Status v1
Start date2018-06→2018-10
2018-04-05
Original filing
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.
Trial Details
NCT Number NCT03495427
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Progenics Pharmaceuticals, Inc.
Conditions Prostate Cancer, Recurrent Prostate Cancer
Enrollment 60 participants
Start Date 2019-12-18
Primary Completion 2029-02 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-02