Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT05245435
Eligibility Criteria:
Inclusion Criteria:
COHORT A:
* Age 18-75 years
* Histologically confirmed oligometastatic adenocarcinoma of the prostate (defined as ≤5 metastases in lymph node (LN) or bone)
* Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
* Planned cytoreductive radical prostatectomy
* ≤ 5 osseous and/or lymph node metastasis
* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures
COHORT B:
* Age 18-75 years
* Histologically confirmed oligometastatic adenocarcinoma of the prostate
* Newly diagnosed metastatic hormone-sensitive disease
* planned therapy with androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures
COHORT C:
* Age 18-75 years
* Histologically confirmed oligometastatic adenocarcinoma of the prostate
* Metastatic castration-resistant disease
* Not pre-treated with enzalutamide or abiraterone acetate
* Planned therapy with abiraterone acetate, or enzalutamide
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures
COHORT D (control group for Cohort A):
* Age 18-75 years
* Histologically confirmed oligometastatic adenocarcinoma of the prostate (defined as ≤5 metastases in lymph node (LN) or bone)
* Hormone-sensitive prostate cancer
* Refused cytoreductive radical prostatectomy
* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures
Exclusion Criteria:
COHORT A:
* HIV positive
* Any contraindication for surgery
* Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
* Any contraindication for performing a PET/MRI scan
* Patient's not eligible for the size of the PET/MRI gantry
COHORTS B and C:
* HIV positive
* Any contraindication for tissue biopsy (if tissue biopsy is planned)
* Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
* Any contraindication for performing a PET/MRI scan
* Patient's not eligible for the size of the PET/MRI gantry
COHORT D (control group for Cohort A):
* HIV positive
* Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
* Any contraindication for performing a PET/MRI scan
* Patient's not eligible for the size of the PET/MRI gantry
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05245435
Study Brief:
Protocol Section:
NCT05245435