Study on patients with recurrence of prostate cancer with PET/MR

Phase 1

• Conditions: Radically treated patient for prostate cancer presenting a biochemical recurrence of disease (PSA: > o = 0.2 ng/mL); MedDRA version: 21.1Level: LLTClassification code 10026389Term: Malignant neoplasm of prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001036-21-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-06
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

- Patients with histological diagnosis of prostate cancer.
- Patients treated with radical therapy (radical prostatectomy or external beam radiotherapy, with or without adjuvant therapy) showing a serum increase in PSA values = 0.2 ng / mL.
- Age = 18 years.
- Able to sign the informed consent for the execution of the examination.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Patients <18 years.
- Medical conditions that may significantly interfere with study compliance.
- Prior or ongoing hormone therapy.
- Contraindications to the PET / MR study (eg pacemaker wearers, etc.)

Study & Design

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