Who is sponsoring NCT04685811?

NCT04685811 is sponsored by Weill Medical College of Cornell University.

What drugs are being tested in NCT04685811?

Interventions in NCT04685811: 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron.

What condition does NCT04685811 study?

NCT04685811 studies Metastatic Prostate Adenocarcinoma.

Is NCT04685811 still recruiting?

NCT04685811 is currently completed. Last updated 22 September 2022.

Are results published for NCT04685811?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-22 · How we verify

NCT04685811

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of PSMA Antagonist Produced by Two Different Methods

Completed Phase 1, PHASE2 Results posted Last updated 22 September 2022

What this trial tests

Phase 1, PHASE2 trial testing 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron in Metastatic Prostate Adenocarcinoma in 16 participants. Completed in 30 June 2021.

Timeline

9 December 2020

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	16
Start date	9 December 2020
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron — full drug profile →

Conditions studied

Metastatic Prostate Adenocarcinoma — all drugs for Metastatic Prostate Adenocarcinoma →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 21 to 100, male only, with Metastatic Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions Primary · 2 study visits between 24 to 48 hours apart

Single score Intraclass Correlation Coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying pathologic lesions. The ICC, based on a one-way random effects model was used to assess reliability. The ICC ratios in this data shows the top five lesions with the greatest PSMA uptake (SUV) in each patient. This is a measure of the variance of interest (for the patient's lesion) over the total variance (from all data points for that particular lesion of interest). Repeatability was evaluated by calculating the variance among gr

Lesion 1

Group	Value	95% CI
Comparison of Generator PSMA Scan vs. Cyclotron PSMA Scan	0.98	0.94 – 0.99

Lesion 2

Group	Value	95% CI
Comparison of Generator PSMA Scan vs. Cyclotron PSMA Scan	0.98	0.95 – 0.99

Lesion 3

Group	Value	95% CI
Comparison of Generator PSMA Scan vs. Cyclotron PSMA Scan	0.99	0.96 – 1.00

Lesion 4

Group	Value	95% CI
Comparison of Generator PSMA Scan vs. Cyclotron PSMA Scan	0.99	0.96 – 1.00

Lesion 5

Group	Value	95% CI
Comparison of Generator PSMA Scan vs. Cyclotron PSMA Scan	0.97	0.91 – 0.99

Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Average SUV Max-pathologic Regions Primary · 2 study visits between 24 to 48 hours apart

Single score intraclass correlation coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying average SUV Max-pathologic regions The ICC ratios in this data provides a general performance review of uptake in both pathological lesions and reference lesions, specifically the average SUVmax of bone metastases, lymph nodes, salivary glands, and the spleen.

Average SUV Max - Bone Lesions

Group	Value	95% CI
Comparison of Generator PSMA Scan vs Cyclotron PSMA Scan	0.96	0.88 – 0.99

Average SUV Max - Lymph Nodes

Group	Value	95% CI
Comparison of Generator PSMA Scan vs Cyclotron PSMA Scan	0.86	0.62 – 0.95

Average SUV Max - Salivary Glands and Parotids

Group	Value	95% CI
Comparison of Generator PSMA Scan vs Cyclotron PSMA Scan	0.70	0.34 – 0.88

Average SUV Max - Spleen

Group	Value	95% CI
Comparison of Generator PSMA Scan vs Cyclotron PSMA Scan	0.82	0.57 – 0.93

ICC Between Generator PSMA Scan vs Cyclotron PSMA Scan: Total Lesion Average SUVMax Primary · 2 study visits between 24 to 48 hours apart

Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The intraclass correlation coefficient (ICC), based on a one-way random effects model (i.e., assumes subjects are randomly selected from the larger population), was used to assess reliability between generator and cyclotron scanning methods. BlandAltman analysis evaluated the agreement between the two scanning methods. Confidence levels of 95% were estimated to assess precision of the obtained estimat

Group	Value	95% CI
ICC Between Generator PSMA Scan vs Cyclotron PSMA Scan: Total Lesion Average SUVMax	0.97

Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Max SUV -Pathologic Regions Secondary · 2 study visits between 24 to 48 hours apart

Single score intraclass correlation coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying Max SUV -pathologic regions Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The intraclass correlation coefficient (ICC), based on a one-way random effects model (i.e., assumes subjects are randomly selected from the larger population), was used to assess reliability between generato

Max SUV - Aorta

Group	Value	95% CI
Comparison of Generator PSMA Scan vs Cyclotron PSMA Scan: MAX SUV	0.59	0.17 – 0.84

Max SUV - Liver

Group	Value	95% CI
Comparison of Generator PSMA Scan vs Cyclotron PSMA Scan: MAX SUV	0.91	0.76 – 0.97

Max SUV - Parotid

Group	Value	95% CI
Comparison of Generator PSMA Scan vs Cyclotron PSMA Scan: MAX SUV	0.78	0.48 – 0.92

Compare Bio-Distribution Between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator Secondary · 2 study visits between 24 to 48 hours apart

The biodistribution of 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator will be evaluated by measuring the radioactivity concentration in various organs of interest. Based on the SUVmean and SUVmax, the RC unit will be used to compare these scans. PSMA positivity was defined as having a SUV value above that of the reference blood pool, liver, and/or salivary glands when evaluating lesions as described using the PROMISE criteria15. Quantitative analysis reviewed the SUVmax and SUVmean of the parotid gland, liver, and aortic arch (blood pool), as well as the SUVmax and SUVmean of suspected metast

Total Lesion Average Coefficient Variation

Group	Value	95% CI
Comparison Between Generator PSMA vs Cyclotron PSMA	0.97	0.92 – 0.99

Total Lesion Average Standard Deviation

Group	Value	95% CI
Comparison Between Generator PSMA vs Cyclotron PSMA	0.94	0.85 – 0.98

Total Lesion Average SUV Max

Group	Value	95% CI
Comparison Between Generator PSMA vs Cyclotron PSMA	0.97	0.91 – 0.99

Total Lesion Average SUV Mean

Group	Value	95% CI
Comparison Between Generator PSMA vs Cyclotron PSMA	0.71	0.36 – 0.89

Sponsor's own description

Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Metastatic Prostate Adenocarcinoma

Currently open trials in the same condition.

NCT06931340 — Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastati · Phase 3 · recruiting
NCT06236139 — Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate · Phase 1, PHASE2 · recruiting
NCT06145633 — Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer · Phase 2 · recruiting
NCT06039371 — Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA St · Phase 2 · recruiting
NCT05689021 — CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations · Phase 2 · active not recruiting

Other Weill Medical College of Cornell University trials

Trials by the same sponsor.

NCT07485712 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2 · NA · not yet recruiting
NCT05811338 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1 · NA · not yet recruiting
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NCT06818734 — Implementation of a Clinical Decision Support Tool for Postpartum Depression · NA · not yet recruiting
NCT07485725 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 3 · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04685811 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
Last refreshed: 22 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04685811.

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