Study on patients with recurrence of prostate cancer with PET/MR

Phase II monocentric study on prostate cancer restaging using PET/MR with innovative radiotracers - PCa Restaging- PET/MR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001036-21-IT

Enrollment

Registered

2018-11-06

Start date

2020-03-04

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radically treated patient for prostate cancer presenting a biochemical recurrence of disease (PSA: > o = 0.2 ng/mL) MedDRA version: 21.1 Level: LLT Classification code 10026389 Term: Malignant neoplasm of prostate System Organ Class: 100000004864

Interventions

Product Name: 68GA-PSMA-HBED-CC Product Code: [68GA-PSMA-HBED-CC] Pharmaceutical Form: Solution for injection INN or Proposed INN: PSMA-HBED-CC (PSMA-11) Current Sponsor code: 68Ga-PSMA Other descript

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Patients with histological diagnosis of prostate cancer. - Patients treated with radical therapy (radical prostatectomy or external beam radiotherapy, with or without adjuvant therapy) showing a serum increase in PSA values = 0.2 ng / mL. - Age = 18 years. - Able to sign the informed consent for the execution of the examination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Patients <18 years. - Medical conditions that may significantly interfere with study compliance. - Prior or ongoing hormone therapy. - Contraindications to the PET / MR study (eg pacemaker wearers, etc.)

Design outcomes

Primary

Measure	Time frame
Main Objective: Provide an innovative approach to restaging patients with biochemical recurrence of prostate cancer by hybrid PET/MR imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina).;Secondary Objective: - Evaluation of the diagnostic accuracy of 68Ga-PSMA PET/MR in the identification of recurrence sites in patients with biochemical recurrence of prostate cancer after primary treatment and comparison with the performance of 68Ga-Bombesina PET/MR. - Correlation between the findings described in the imaging with 68Ga-PSMA and 68Ga-Bombesina PET/MR with the clinical and histopathological characteristics. - Evaluate the impact of targeted therapy on lesions in terms of biochemical recurrence-free survival and clinical disease recurrence-free survival. In particular, patients will be identified who will be more able to benefit from this targeted approach, in terms of positive imaging prediction and response to local treatment of recurrence sites with surgery or radiotherapy.;Primary end point(s): Provide an innovative approach to restaging patients with biochemical recurrence of prostate cancer by hybrid PET/MR imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina).;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Main Objective: Provide an innovative approach to restaging patients with biochemical recurrence of prostate cancer by hybrid PET/MR imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina).;Secondary Objective: - Evaluation of the diagnostic accuracy of 68Ga-PSMA PET/MR in the identification of recurrence sites in patients with biochemical recurrence of prostate cancer after primary treatment and comparison with the performance of 68Ga-Bombesina PET/MR. - Correlation between the findings described in the imaging with 68Ga-PSMA and 68Ga-Bombesina PET/MR with the clinical and histopathological characteristics. - Evaluate the impact of targeted therapy on lesions in terms of biochemical recurrence-free survival and clinical disease recurrence-free survival. In particular, patients will be identified who will be more able to benefit from this targeted approach, in terms of positive imaging prediction and response to local treatment of recurrence sites with surgery or radiotherapy.;Primary end point(s): Provide an innovative approach to restaging patients with biochemical recurrence of prostate cancer by hybrid PET/MR imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina).;Timepoint(s) of evaluation of this end point: 36 months

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Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the diagnostic accuracy of 68Ga-PSMA PET/MR in the identification of relapse sites in patients with biochemical recurrence of prostate cancer after primary treatment and comparison with the performance of 68Ga-Bombesina PET/MR.; Correlation between the findings described in the imaging with 68Ga-PSMA and 68Ga-Bombesina PET/MR with the clinical and histopathological characteristics.; Evaluate the impact of targeted wound therapy in terms of biochemical recurrence-free survival and clinical disease recurrence-free survival. In particular, patients will be identified who will be more able to benefit from this targeted approach, in terms of positive imaging prediction and response to local treatment of recurrence sites with surgery or radiotherapy.;Timepoint(s) of evaluation of this end point: 36 months; 36 months; 36 months	—

Measure

Time frame

Secondary end point(s): Evaluation of the diagnostic accuracy of 68Ga-PSMA PET/MR in the identification of relapse sites in patients with biochemical recurrence of prostate cancer after primary treatment and comparison with the performance of 68Ga-Bombesina PET/MR.; Correlation between the findings described in the imaging with 68Ga-PSMA and 68Ga-Bombesina PET/MR with the clinical and histopathological characteristics.; Evaluate the impact of targeted wound therapy in terms of biochemical recurrence-free survival and clinical disease recurrence-free survival. In particular, patients will be identified who will be more able to benefit from this targeted approach, in terms of positive imaging prediction and response to local treatment of recurrence sites with surgery or radiotherapy.;Timepoint(s) of evaluation of this end point: 36 months; 36 months; 36 months

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Countries

Italy

Contacts

Public ContactMedicina Nucleare

IRCCS Ospedale San Raffaele

incerti.elena@hsr.it0226432717

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026