68Ga-PSMA-PET/CT

Phase 1

• Conditions: Biochemical recurrence in patients with prostate cancer after radical prostatectomy and/or radiotherapy, no CRPC status; MedDRA version: 21.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: LLTClassification code 10036223Term: Positron emission tomographySystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004371-51-IT
• Lead Sponsor: AZIENDA USL DELLA VALLE D'AOSTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 62

Inclusion Criteria

1.Age>45

2.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigationale nature of study

3.ECOG 0-1

4.Hystologically confirmed prostate cancer

5.Previous prostatectomy and/or radiotherapy

6.Biochemical recurrence confirmed by elevated PSA value following initial therapy (recent blood test results up to 4 weeks):
-For patients status post prostatectomy, a PSA >/= 0.2 ng/ml and < 4 ng/ml
-For patient status post radiation therapy for prostate cancer, any PSA increase from radiation therapy nadir but < 4 ng/ml

7.Recent blood test results (up to 4 weeks) as follows: WBC=3000/mm3 , Absolute neutrophil count ANC=1500/mm3, PLT=100000/mm3 , Hb=10 g/dl, Total bilirubin = 2.0 mg/dL, ALT and AST = 2.5 x the upper limit of normal, Serum creatinine <1.5 x ULN
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Inability to stay lay for the entire imaging time (e.g. cough, severe arthritis, etc)

2.Inability to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc)

3.Patients with known CRPC status, as defined by EAU Guidelines and urologists or medical oncologists evaluation

4.Prior or concomitant chemotherapy

5.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug

6.Patients exceeding the weight limitations of the scanner ore are not able to enter the bore of the PET scanner due to BMI

7.Other concomitant or previous malignancies, with the exception of basal cell skin tumors/superficial bladder cancer and any cancer that has been in complete remission for > 5 years.

8.Recovery from major trauma including surgery within 4 weeks prior to PET imaging

9.Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Sensitivity of 68Ga-PSMA PET/CT imaging in detection of recurrent prostate cancer in patient with low PSA level (<4 ng/ml);Secondary Objective: Correlation of detection rate with PSA value, primary Gleason Score and antiandrogen therapy<br><br>Clinical management changes based on PET imaging findings<br>;Primary end point(s): Ability of 68Ga-PSMA PET/CT to identify prostate cancer recurrence in patient with low PSA level (<4 ng/ml);Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Correlation of detection rate with PSA value, primary Gleason Score and antiandrogen therapy;Timepoint(s) of evaluation of this end point: 12 months