64CuCl2 PET/CT VS 18F-choline PET/CT in prostate cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

A.C.O.M. Advanced Center Oncology Macerata S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2025-02-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520861-29-00

EudraCT number

2019-000744-10

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis

The study design is based on a co-primary endpoint for the evaluation of the diagnostic performance in terms of sensitivity and specificity of 64CuCl2 PET/CT compared to 18Fcholine PET/CT.
The evaluation of sensitivity and specificity for the co-primary endpoint is expressed on a patient basis, in relation to the entire individual.

Secondary objectives 7

1. To evaluate the higher diagnostic accuracy of 64CuCl2 PET/CT compared to 18F-FCH PET/CT in identifying metastatic patients (diagnostic performance).
2. To estimate the sensitivity and specificity between the two PET/CT scans (64CuCl2 and 18F choline) on a body region basis (chest, abdomen, pelvis) and on a lesion basis (bone, lymph nodes, visceral) (diagnostic performance).
3. To correlate the sensitivity of 64CuCl2 PET/CT and 18F choline PET/CT at different PSA levels (diagnostic performance).
4. To assess the rate of patients in whom the stage is changed (oligometastatic vs. polymetastatic patient) using 64CuCl2 PET/CT and to evaluate the impact on clinical strategy and therapeutic decision-making (impact on patient management).
5. Evaluate the 64Cu PET/CT impact on decision thinking (impact of the test versus pre-test probability) by positive and negative predictive values (impact on decision thinking).
6. Evaluate the impact of 64Cu PET/CT result on clinical outcome by patient follow-up data and in particular the consequences of incorrect diagnosis (treatment delay or unnecessary interventions) (impact on patient management).
7. Assessing the inter- and observer reproducibility of 64Cu PET/CT (technical performance).

Conditions and MedDRA coding

Prostate cancer at risk of developing metastatic lesions

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Age >=45 years at the enrolment time.
2. Previous documented histological diagnosis of primary prostate adenocarcinoma.
3. Clinical indication on staging or restaging.
4. Imaging examination MRI and/or TAC and/or Bone Scan and/or PET and/or other imaging techniques.
5. Patient at risk of developing metastasis during their illness according to symptoms presence or EAU criteria of risk as follows:Class A: high-risk patients before primary treatment: PSA> 20 or GS> 7 or cT2c; or any PSA also Gs cT3-4 or cN +, histological confirmation in the prostate and lymph nodes (if possible), for patients who have not already started radiotherapy. Class B: re-staging after the primary treatment: PSA value 0,2 ng/ml in two different consecutive measurements or 2 ng/ml increase in serum PSA over the PSA nadir value. Class C: post-staging for biochemical progression during treatment; (CRPC); three consecutive increases in PSA at least one week apart, resulting in two 50% increases above nadir and a PSA>2ng/ml.
6. Negative medical history of other previous or ongoing neoplastic diseases, with the exception of non-melanoma skin carcinomas.
7. Karnofski index ≥ 80%.
8. No other relevant comorbidities (see exclusion criteria).
9. Full comprehension of the information contained in the illustrative documentation for the Subject.
10. Full capacity to sign informed consent.

Exclusion criteria 9

1. Anemia with Hb value<9 gr/dL.
2. Symptoms or signs of sepsis and/or evidence of acute infections.
3. AST value>1.5 higher than normal range.
4. ALT value>1.5 higher than normal range.
5. Total Bilirubin value>1.5 higher than normal range.
6. Copper metabolism disease (Menkes disease, Wilson disease).
7. Previous participation to clinical trials with ionizing radiation for therapeutic scope.
8. Any condition, material, logistics, or Subjective, which, even in the Principal Investigator’s opinion, may condition the subject's compliance with the execution of the procedures established by the Protocol.
9. Inability to understand the content of the information documents for the Subject.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To evaluate the diagnostic performance in terms of sensitivity and specificity of 64Cu PET/CT versus 18F-choline PET/CT on a patient basis, in relation to the whole individual. In particular, 18F-choline PET/CT and 64CuCl2 PET/CT will be evaluated as positive (PET+) in case of evidence of pathological focal uptake in correspondence with site(s) compatible with metastases (bone, lymph node and visceral;otherwise they will be judged negative (PET-) when no pathological focal uptakes are detectable

Secondary endpoints 7

1. The diagnostic accuracy of the two PET/CT (64Cu and 18F-choline) will be assessed by area under the ROC curve (AUC) and the difference in the curve between the two methods will be evaluated.
2. Sensitivity and specificity on a lesion-based and region-based basis will be analysed by aggregation according to body region (chest, abdomen, pelvis) and anatomo-pathological character of the lesions (bone, lymph node, visceral).
3. The sensitivity 64Cu PET and 18F-choline will be correlated with PSA levels and calculated as for the primary objective.
4. Patients will be classified into non-metastatic, oligometastatic and multimetastatic with both PET/CT. (A patient with up to three metastases will be defined as oligometastatic).
5. In each patient the different impact of the two PET scans on decision-making (impact of the test versus pre-test probability) will be assessed with calculation of positive and negative predictive values.
6. In each patient the impact determined by the 64Cu PET/CT on clinical outcome will be evaluated by means of the patient's follow-up data and in particular the consequences of misdiagnosis (delay of treatment or unnecessary intervention) will be assessed.
7. The inter-observer reproducibility of 64CuCl2 and 18F-FCH PET/CT will be evaluated.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

A.C.O.M. Advanced Center Oncology Macerata S.r.l.

Sponsor organisation

A.C.O.M. Advanced Center Oncology Macerata S.r.l.

Address

Via Cavallino 39/ab

City

Montecosaro

Postcode

62010

Country

Italy

Scientific contact point

Organisation

A.C.O.M. Advanced Center Oncology Macerata S.r.l.

Contact name

Contact Point

Public contact point

Organisation

A.C.O.M. Advanced Center Oncology Macerata S.r.l.

Contact name

Contact Point

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications