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Prostate CancerPhase 2NCT07635524

A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.

A Phase 2 study testing Cu-NU101 in people with Prostate Cancer, run by Hoag Memorial Hospital Presbyterian at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Cu-NU101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesUnited States
Study dates
1 Aug 2026to 1 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven prostate adenocarcinoma
  • Age ≥ 18 years
  • ECOG 0 or 2 4 .Oligometastatic disease (1-5 radiotracer avid disease sites) on 18F- piflufolastat PET/CT within 30 days of trial recruitment

Who cannot join

  • Known allergy/hypersensitivity to PSMA-targeted imaging agents
  • Other active malignancy, other than the known prostate cancer

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gary Ulaner, MD, PhD contact

949-557-0285

gary.ulaner@hoag.org

Beth Thomsen, CNMT contact

949-557-0285

beth.thomsen@hoag.org

United States2 sites

  • Hoag Family Cancer Institute

    Newport Beach, California, 92663

    Beth Thomsen, CNMT, CRC, 949-557-0285, beth.thomsen@hoag.org

    Gary Ulaner, MD, PhD

  • Washington Univeristy School of Medicine

    St Louis, Missouri, 63110

    Vikas Prasad

Other trials in United States

About this study

Official title: A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer

The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases.

34 participants with biopsy-proven prostate cancer and cancer seen on a Pylarify PET scan will be enrolled in this study.

The investigational 61Cu-NU101 PET/CT will be perfromed. If there is a difference between the standard Pylarify exam and the investigational 61Cu-NU101 exam, a biopsy of one lesion that is different between the two exams may be performed.

Read the detailed description

This is an open, phase 2, two center, non-randomized trial. Total of 34 subjects are planned, based on a statistical analysis to provide 80% power to determine non-inferiority of 61Cu-NU101 as compared to 18F-piflufolastat PET/CT. Each participant will have biopsy-proven prostate cancer visualized on standard-of-care 18F-piflufolastat PET/CT performed within 30 days of trial accrual. If participants have not had a diagnostic quality CT and/or a bone scan within 30 days of trial accrual, then will undergo a diagnostic quality CT and/or bone scan, as needed. Participants will undergo a research 61Cu-NU101 PET/CT, as follows: Each subject will receive a single administration of 61Cu-NU101, followed by PET/CT imaging at 1 and 4 hours. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection. Safety of 61Cu-NU101 will be evaluated by monitoring for unlikely adverse events. Ability of 61Cu-NU101to visualize malignant lesions will be evaluated by comparing the number of suspicious lesions demonstrated on the standard-of-care 18F-piflufolastat PET/CT with the number of suspicious lesions demonstrated on the experimental 61Cu-NU101PET/CT. Positive lesions will be considered to be foci greater than local background that are not physiologic/benign by location. If there is a discrepancy between the number of lesions detected by 18F-piflufolastat PET/CT and 61Cu-NU101PET/CT, then a discrepant lesion will be selected for biopsy to provide pathologic proof as a reference standard, if possible.

Determination of lesions suspicious for malignancy on 18F-piflufolastat PET/CT and 61Cu-NU101: The previously performed standard-of-care 18F-piflufolastat PET/CT and the on-trial research 61Cu-NU101will be evaluated using the same methodology, by radiologists with expertise in the interpretation of PSMA-targeted PET/CT imaging. Abnormal tracer accumulation will be defined as areas of uptake outside of sites considered physiologic or inflammatory. The locations of focal tracer abnormalities will be recorded. Radiotracer uptake will be graded on a scale of 1-5 where 1 = definitely normal, 2 = probably normal, 3 = equivocal, 4 = probably abnormal, and 5 = definitely abnormal. Semiquantitative analysis of tracer uptake will be performed for grade 4 and 5 lesions. Three-dimensional regions of interest (ROIs) will be placed in areas of tracer uptake and used for quantification of standardized uptake value (SUV), calculated as: SUV = decay-corrected mean ROI activity (μCi/ml) / (injected dose (μCi)/ body weight (g)). SUVmax will be recorded. Lesions graded as 4 (probably abnormal) or 5 (definitely abnormal) for malignancy will be counted and included in the number on lesions suspicious for malignancy in each examination.

Determination of lesions suspicious for malignancy on CT and bone scan: As a secondary objective, the number of lesions suspicious for malignancy will be compared between 61Cu-NU101and standard-of-care CT/bone scan. CT and bone scan will be interpreted by radiologists with expertise in the interpretation in CT and bone scans. Abnormal findings on CT and bone scan will be graded on a scale of 1-5 where 1 = definitely normal, 2 = probably normal, 3 = equivocal, 4 = probably abnormal, and 5 = definitely abnormal. No quantitative measurements will be made on CT and bone scan. For osseous lesions, a corresponding lesion on CT and bone scan will be counted as only 1 lesion. Lesions graded as 4 (probably abnormal) or 5 (definitely abnormal) for malignancy will be counted and included in the number on lesions suspicious for malignancy.

Conditions
Prostate Cancer
Being tested
Cu-NU101
Keywords
prostate, cancer, metastatic, radiotracer, metastases
Medical subject headings
Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cu-NU101Drug

    Subjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +/-10% , followed by PET/CT imaging 1 hour (+/- 10 minutes) and 4 hours (+/- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.

Study groups in NCT07635524
Study groupRoleWhat they receive
Cu-NU101ExperimentalSubjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +/-10% , followed by PET/CT imaging 1 hour (+/- 10 minutes) and 4 hours (+/- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.
Receives: Drug: Cu-NU101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of imaging with 61Cu- NU101,

    Demonstrate the sensitivity of imaging with 61Cu- NU101, as compared to a currently standard of care PSMA-targeted imaging agent, 18F-piflufolastat.

    Measured: 4 hours post-administration

Secondary outcomes (1)

  1. Assessing the sensitivity of the 61Cu-NU101 scan

    Sensitivity will be determined by comparing the lesions identified with 61Cu-NU101 against those identified with standard-of-care 18F-piflufolastat, with histology as the reference standard.

    Measured: 1 hour post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635524
Sponsor's protocol ID
149-25-CA
Status last verified
Apr 2026
First submitted
3 Jun 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Roberts MJ, Maurer T, Perera M, Eiber M, Hope TA, Ost P, Siva S, Hofman MS, Murphy DG, Emmett L, Fendler WP. Using PSMA imaging for prognostication in localized and advanced prostate cancer. Nat Rev Urol. 2023 Jan;20(1):23-47. doi: 10.1038/s41585-022-00670-6. Epub 2022 Dec 6.

    PubMed 36473945

  • Ulaner GA, Bassett JC, Reddy R, Thomsen B, Reynolds D, Jerjian KJ, Wolfe R, Benjamin DJ, Fani M, O'Donoghue J, Baier M, Schubert N, Pais B, De Rose F, Jaafar L. 61Cu-NODAGA Prostate-specific Membrane Antigen Imaging and Therapy for Prostate Cancer: Phase 1 Trial of a New Class of 61Cu-labeled PET Radiotracers. Radiology. 2025 Dec;317(3):e251151. doi: 10.1148/radiol.251151.

    PubMed 41363974

  • van der Gaag S, Bartelink IH, Vis AN, Burchell GL, Oprea-Lager DE, Hendrikse H. Pharmacological Optimization of PSMA-Based Radioligand Therapy. Biomedicines. 2022 Nov 23;10(12):3020. doi: 10.3390/biomedicines10123020.

    PubMed 36551776

  • Chatalic KL, Heskamp S, Konijnenberg M, Molkenboer-Kuenen JD, Franssen GM, Clahsen-van Groningen MC, Schottelius M, Wester HJ, van Weerden WM, Boerman OC, de Jong M. Towards Personalized Treatment of Prostate Cancer: PSMA I&T, a Promising Prostate-Specific Membrane Antigen-Targeted Theranostic Agent. Theranostics. 2016 Apr 12;6(6):849-61. doi: 10.7150/thno.14744. eCollection 2016.

    PubMed 27162555

  • Lawhn-Heath C, Salavati A, Behr SC, Rowe SP, Calais J, Fendler WP, Eiber M, Emmett L, Hofman MS, Hope TA. Prostate-specific Membrane Antigen PET in Prostate Cancer. Radiology. 2021 May;299(2):248-260. doi: 10.1148/radiol.2021202771. Epub 2021 Mar 30.

    PubMed 33787338

  • Yilmaz U, Komek H, Can C, Altindag S. The role of (68Ga)PSMA I&T in biochemical recurrence after radical prostatectomy: detection rate and the correlation between the level of PSA, Gleason score, and the SUVmax. Ann Nucl Med. 2019 Aug;33(8):545-553. doi: 10.1007/s12149-019-01360-x. Epub 2019 May 8.

    PubMed 31069696

  • Komek H, Can C, Yilmaz U, Altindag S. Prognostic value of 68 Ga PSMA I&T PET/CT SUV parameters on survival outcome in advanced prostat cancer. Ann Nucl Med. 2018 Oct;32(8):542-552. doi: 10.1007/s12149-018-1277-5. Epub 2018 Jul 13.

    PubMed 30006752

  • Cytawa W, Seitz AK, Kircher S, Fukushima K, Tran-Gia J, Schirbel A, Bandurski T, Lass P, Krebs M, Polom W, Matuszewski M, Wester HJ, Buck AK, Kubler H, Lapa C. 68Ga-PSMA I&T PET/CT for primary staging of prostate cancer. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):168-177. doi: 10.1007/s00259-019-04524-z. Epub 2019 Sep 16.

    PubMed 31529265

  • Follacchio GA, De Feo MS, De Vincentis G, Monteleone F, Liberatore M. Radiopharmaceuticals Labelled with Copper Radionuclides: Clinical Results in Human Beings. Curr Radiopharm. 2018;11(1):22-33. doi: 10.2174/1874471011666171211161851.

    PubMed 29231149

  • Amanuel FK. Nuclear model prediction for production of medical 22Na, 51Cr, 60Co, 61Cu, 64Cu, 65Zn, 67, 68Ga, 88Y and 99Mo radionuclides: Comparison of experimental and theoretical data. Appl Radiat Isot. 2021 Jun;172:109674. doi: 10.1016/j.apradiso.2021.109674. Epub 2021 Mar 3.

    PubMed 33684656

  • Ulaner GA, Thomsen B, Bassett J, Torrey R, Cox C, Lin K, Patel T, Techasith T, Mauguen A, Rowe SP, Lindenberg L, Mena E, Choyke P, Yoshida J. 18F-DCFPyL PET/CT for Initially Diagnosed and Biochemically Recurrent Prostate Cancer: Prospective Trial with Pathologic Confirmation. Radiology. 2022 Nov;305(2):419-428. doi: 10.1148/radiol.220218. Epub 2022 Jul 19.

    PubMed 35852431

  • Jadvar H, Calais J, Fanti S, Feng F, Greene KL, Gulley JL, Hofman M, Koontz BF, Lin DW, Morris MJ, Rowe SP, Royce TJ, Salami S, Savir-Baruch B, Srinivas S, Hope TA. Appropriate Use Criteria for Prostate-Specific Membrane Antigen PET Imaging. J Nucl Med. 2022 Jan;63(1):59-68. doi: 10.2967/jnumed.121.263262. Epub 2021 Sep 30. No abstract available.

    PubMed 34593595

  • Morris MJ, Rowe SP, Gorin MA, Saperstein L, Pouliot F, Josephson D, Wong JYC, Pantel AR, Cho SY, Gage KL, Piert M, Iagaru A, Pollard JH, Wong V, Jensen J, Lin T, Stambler N, Carroll PR, Siegel BA; CONDOR Study Group. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021 Jul 1;27(13):3674-3682. doi: 10.1158/1078-0432.CCR-20-4573. Epub 2021 Feb 23.

    PubMed 33622706

  • Pienta KJ, Gorin MA, Rowe SP, Carroll PR, Pouliot F, Probst S, Saperstein L, Preston MA, Alva AS, Patnaik A, Durack JC, Stambler N, Lin T, Jensen J, Wong V, Siegel BA, Morris MJ. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). J Urol. 2021 Jul;206(1):52-61. doi: 10.1097/JU.0000000000001698. Epub 2021 Feb 26.

    PubMed 33634707

  • Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.

    PubMed 34529005

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cu-NU101 in people with Prostate Cancer, run by Hoag Memorial Hospital Presbyterian at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gary Ulaner, MD, PhD (949-557-0285, gary.ulaner@hoag.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of imaging with 61Cu- NU101, (time frame: 4 hours post-administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07635524, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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