Role of PET/ CT with 18F-fluorocholine in the staging of patients with intermediate/high risk prostate cancer.

Role of PET/ CT with 18F-fluorocholine in the staging of patients with intermediate/high risk prostate cancer. Phase III, randomized, open-label clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002511-99-IT

Enrollment

390

Registered

2013-10-16

Start date

2013-11-25

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Histologically proven prostate cancer with Gleason score =7 and PSA>=10ng/ml or Gleason score >=8 and any PSA level or cT2-T3 and any PSA level or any Gleason score and PSA>=20ng/ml and indication of prostactectomy, radiotherapy or systemic therapy MedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: IASOcholine Product Name: IASOcholine Pharmaceutical Form: Concentrate for solution for injection

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Histologically proven prostate cancer with Gleason score =7 and PSA>=10ng/ml or Gleason score >=8 and any PSA level or cT2-T3 and any PSA level or any Gleason score and PSA>=20ng/ml Age more than 18 years 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 290

Exclusion criteria

Exclusion criteria: Metastatic disease Patients treated with anti-androgen therapy or radiotherapy Previous malignancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Verify whether the additional use of PET/CT with 18F-fluorocholine in the initial staging of prostate cancer improves the sensitivity in defining the loco-regional disease with respect to CT and bone scan.;Secondary Objective: To show whether the use of PET / CT with 18F-fluorocholine modifies the therapeutic approach regarding the use of surgical treatment and / or systemic therapy, evaluate the toxicity of 18F-fluorocholine and the cost-effectiveness of the additional use of PET / CT with 18F-fluorocholine.;Primary end point(s): sensitivity of PET/TC 18F-fluorocholine in defining the loco-regional disease ;Timepoint(s) of evaluation of this end point: Up to 180 days since randomization	—

Measure

Time frame

Main Objective: Verify whether the additional use of PET/CT with 18F-fluorocholine in the initial staging of prostate cancer improves the sensitivity in defining the loco-regional disease with respect to CT and bone scan.;Secondary Objective: To show whether the use of PET / CT with 18F-fluorocholine modifies the therapeutic approach regarding the use of surgical treatment and / or systemic therapy, evaluate the toxicity of 18F-fluorocholine and the cost-effectiveness of the additional use of PET / CT with 18F-fluorocholine.;Primary end point(s): sensitivity of PET/TC 18F-fluorocholine in defining the loco-regional disease ;Timepoint(s) of evaluation of this end point: Up to 180 days since randomization

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Secondary

Measure	Time frame
Secondary end point(s): 1) number of patients undergoing surgery or systemic therapy in each study arm 2) toxicity measured with the National Cancer Institute Common Terminology Criteria for Adverse Events v4 System 3) costs of diagnostic methods and absolute risk reduction for a futile surgery obtained using PET/TC 18F-fluorocholine;Timepoint(s) of evaluation of this end point: Up to 180 days since randomization	—

Measure

Time frame

Secondary end point(s): 1) number of patients undergoing surgery or systemic therapy in each study arm 2) toxicity measured with the National Cancer Institute Common Terminology Criteria for Adverse Events v4 System 3) costs of diagnostic methods and absolute risk reduction for a futile surgery obtained using PET/TC 18F-fluorocholine;Timepoint(s) of evaluation of this end point: Up to 180 days since randomization

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Countries

Italy

Contacts

Public ContactGIAN LUCA DE SALVO

ISTITUTO ONCOLOGICO VENETO

clinical.trial@ioveneto.it00390498215704

Outcome results

None listed

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