Biochemical recurrent prostate cancer MedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 18F-PSMA
Product Code: [18F-PSMA]
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: 18F-PSMA
Current Sponsor code: 18F-PSMA
Other descriptive name: 18F-PSMA
Concentration u
Sponsors
OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histological confirmation of prostate malignancy. 2. Patient must have had their primary tumor treated with surgery and/or radiation and salvage radiation to the prostate bed or pelvis is allowed. 3. Patient must be = 18 years of age, have the ability to understand, and the willingness to sign, a written informed consent document. 4. Patient must have an Eastern Cooperative Oncology Group performance status = 2. 5. Diagnosis of biochemical failure: For patients treated with surgery: arise of PSA = 0.2 ng/ml. For patients treated with radical RT: PSA level +2 ng/ml from nadir. 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 358 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 536
Exclusion criteria
Exclusion criteria: 1. More than 3 years of ADT, with the most recent ADT treatment having occurred < 6 months prior to enrollment. 2. Spinal cord compression or impending spinal cord compression. 3. Receipt of any other investigational agents in the previous 3 months 4. Inability to lie flat during or tolerate PET/CT. 5. Refusal to sign informed consent 6. Participation in a concurrent clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic performance of 18F-PSMA versus 18F-Choline, in detecting relapses of prostate cancer. We hypothesize that the 18F-PSMA diagnostic performance is at least 20% higher respect to that of the 18F-Choline tracer.;Secondary Objective: To analyze if the use of 18F-PSMA, by an early detection of metastases, optimizes the overall management of the patient, allowing for example targeted radiotherapeutic interventions instead of systemic pharmacological treatments.;Primary end point(s): 18F-PSMA or choline tests results at Visit 2 by all experts; the test will be considered positive when two expert examiners (+ 5000 examinations performed) will agree on the lesion(s), or negative when both experts will judge the injury as negative. Results from patients with diagnostic uncertainty will be reassessed by a third expert to decrease uncertainty and to offer the best diagnosis procedure to the patient.;Timepoint(s) of evaluation of this end point: At visit 2, after TC-PET execution. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease-free time after: • Hormonal therapy, • Radiotherapy, • Watchful observation, • Surgical treatment as per normal clinical practice.;Timepoint(s) of evaluation of this end point: At usual follow.up visit, as per normal clinical practice, every three months for the first year and every 6 months for the following two years. | — |
Countries
Italy
Contacts
Public ContactUnità per la Ricerca Clinica
IRCCS Sacro Cuore Don Calabria
Outcome results
None listed