Interventional two arms open-label study for evaluating the diagnostic performance of PET PSMA in patients affected by biochemical recurrent prostate cancer.

Phase 1

• Conditions: Biochemical recurrent prostate cancer; MedDRA version: 21.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2018-003652-21-IT
• Lead Sponsor: OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 894

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified