Multi-cohort investigational study to evaluate the impact of pelvic mp-3TMRI and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.

Phase 1

• Conditions: prostate cancer; MedDRA version: 20.0Level: LLTClassification code 10001186Term: Adenocarcinoma of prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002651-28-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 306

Inclusion Criteria

COHORT 1: Men aged 45 to 75 years old with clinically-suspected PCa candidated for either initial or repeat TRUS-guided prostate biopsy; COHORT 2: Men consenting to enter the PRIAS MRI side-study COHORT 3a: Male with cyto/histological confirmation of high risk PCa, willing to undergo radical prostatectomy and pelvic lymph node dissection. COHORT 3b: Male with cyto/histological confirmation of PCa, willing to undergo nerve-sparing radical prostatectomy
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 186

Exclusion Criteria

1. Hormone androgen deprivation therapy of any type within 6 months prior to enrollment.
2.Prior pelvic radiotherapy;
3.Sickle cell disease;
4.Insufficient renal function (eGFR < 30 mL/min/1.73 m2);
5.Hip prosthesis, vascular grafting or other conditions affecting imaging;
6.Contraindication to MRI;
7.History of allergic reactions attributed to compounds of similar chemical or biologic com-position to 68Ga-PSMA or Gadolinium-based contrast agents used in the study.
8.Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Study & Design

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