Phase II trial testing Ablative radiotherapy in metastatic prostatecancer, resistant to hormonal therapy and with number of metastatic lesions lower or equal to three.

Phase 1

• Conditions: Oligometastatic prostate cancer, castration resistant; MedDRA version: 21.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-005284-13-IT
• Lead Sponsor: DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 174

Inclusion Criteria

1.Metastatic disease and only minor or equal at 3 metastatic sites recorded (irrespective if nodal or bone).
2. Patients should have received abiraterone acetate for 30 days before start of radiotherapy (+ or – 3 days)
3. Asymptomatic or mildly symptomatic pa-tients according to clinical judgement.

4.Age more and equal 18 years.

5.Subject must have signed an informed consent document indicating that they understand the purpose of procedures required for the study and are willing to participate in the study.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114

Exclusion Criteria

1.More than 3 metastatic lesions.

2.Visceral envolvement.

3.Known or suspected contraindications or hypersensitivity to Abiraterone, GnRH agonist/antagonist or Radiotherapy.
4.Comorbidities that contraindicate Abiraterone, GnRH agonist/antagonist or Radiotherapy.
5.Any condition for which, in the option of the investigator, participation would not be in the best interest of subject.
6.Patients who received previous therapies for mCRPC (excluded ormonal therapy)

Study & Design

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