Phase III clinical trial Oligometastatic and Oligorecurrent PROstate Cancer: enhancing patients’ selection by new ImagiNG biomarkers

Phase 1

• Conditions: Prostate cancer; 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: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10007454Term: Carcinoma of the prostate recurrentSystem 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); Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2018-004458-14-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 246

Inclusion Criteria

Related to PCa:
1. Histologically documented castration resistant PCa treated with radical prostatectomy or loco-regional EBRT.
2. BCR PCa demonstrated by two consecutive PSA determinations
3. Life expectancy of more than 6 months.
Related to the patient:
4. Male patients aged >18 years without upper age limit.
5. Ability to understand and willingness to sign a written informed consent document.
6. Written informed consent obtained according to international guidelines and local laws.
7. Compliant to the study procedures, based on the Investigator point of view.
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 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 185

Exclusion Criteria

Related to the PCa
1. Other malignancies
Related to the patient:
1. Patient not willing to sign a written informed consent document.
2. Patient with severe chronic renal disease (according to the KDOQI/CTCAE eGFR or CrCl< 15 ml/min/1.73m2).

Study & Design

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