Use of the diagnostic PET with 64CuCl2 in order to select patients, in which a disease relapse is shown after prostate surgical removal, to be successfully treated to radiation therapy on the prostate bed.

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

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

Decision date (initial)

2025-02-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520868-17-00

EudraCT number

2017-004332-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Efficacy

The primary objective is to evaluate the diagnostic accuracy of PET with 64CuCl2 in the diagnosis of local recurrence of prostatic carcinoma after radical prostatectomy, in patients negative to traditional methods.

Secondary objectives 6

1. To evaluate the ability to detect relapse sites in subgroups with PSA <0.5 and between 0.5 and 1.
2. To evaluate the clinical impact (treatment modification) of cases with positive 64CuCl2-PET in lymph nodes or for distant metastases (M+).
3. To evaluate all the performance indicators of interest of the 64CuCl2-PET referring to the response after Salvage Radiotherapy.
4. To estimate the median time to reach the minimum value (NADIR) of the PSA in B+ patients.
5. To evaluate the optimal SUV for the detection of index lesions in the prostate bed
6. To evaluate the safety aspects and the surveillance of adverse events.

Conditions and MedDRA coding

Cancer on the prostatic bed

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Age>=45 years at the time of enrollment.
2. Previous documented histological diagnosis of primitive prostate adenocarcinoma.
3. Previous prior radical prostatectomy surgery.
4. Zeroing of circulating PSA values.
5. Presence of biochemical relapse documented by an increase in circulating PSA values in two consecutive determinations (values between 0.2 ng/ml and 1 ng/ml)
6. Absence of distant metastatic lesions not detectable by previous mpMRI and PET/CT imaging tests (18F-choline and/or PSMA).
7. Negative clinical history for other previous or current neoplastic diseases, with the exception of non-melanoma skin carcinomas.
8. Previous execution 18F-FCH PET and/or PSMA PET not older than 30 days.
9. Patients to be treated with salvage radiotherapy to the prostate bed.
10. Previous execution mpMRI and/or US performance not older than 30 days.
11. Karnofski Index >= 80%
12. Absence of other relevant comorbidities (see: exclusion criteria).
13. Full ability to understand the information reported in the informed consent sheet.
14. Full ability to sign informed consent.

Exclusion criteria 14

1. Anemia with Hb <9 gr/dl
2. Subject treated with ADT (orchiectomy, and/or LHRH agonists, and/or androgen antagonists).
3. Presence of symptoms or signs of sepsis and/or evidence of acute infections.
4. AST>1.5 times the upper limit of the normal range.
5. ALT>1.5 times the upper limit of the normal range.
6. Total bilirubin>1.5 times the upper limit of the normal range.
7. Copper metabolism diseases (Menkes’ disease, Wilson’s disease).
8. Subjects who have received chemotherapy in the previous 120 days.
9. Radiotherapy performed in the previous 120 days.
10. Major surgery performed in the previous 120 days.
11. Presence of lesions in the prostatic bed evidenced by previous mpMRI and/or US examinations.
12. Previous participation in clinical trials with exposure to ionizing radiation for therapeutic purposes.
13. Any condition, material, logistics, or Subjective, which, even in the opinion of the Principal Investigator, may condition the subject's compliance with the execution of the procedures established by the Protocol.
14. Inability to understand the contents of the information documentation for the subject.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-).

Secondary endpoints 6

1. Calculation of the maximum variation of PSA in the subgroups of patients with PSA<0.5 and PSA between 0.5 and 1, through the ROC curve and evaluation of the ability to detect sites of recurrence.
2. In each patient the impact that the positive results of 64CuCl2-PET out of the prostatic bed would have had on the therapeutic choice will be evaluated and tabulated, also taking into account the classification of the patient in R+/R-;
3. Sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) will be evaluated.
4. The time between treatment beginning (baseline) and the achievement of the minimum value (NADIR) will be estimated through estimates of Kaplan-Meyer curves.
5. The SUV values of the prostate bed index lesions will be correlated with the actual SRT response, in order to identify the SUV limits below which the uptake is not significant.
6. Adverse events will be recorded and classified according to the EMA guidelines.

Investigational products

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

Test 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 · 4 investigational sites

By country

Investigational sites

Results and documents

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

Documents 4 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