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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT05707468
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate without small cell features
* Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT
* \<4 bone oligometastases, lymph node metastasis below the renal artery level
* Expected survival time \>5 years
* World Health Organization (WHO) performance status 0-1
* Be willing to give written informed consent.
Exclusion Criteria:
* Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.
* Patients who have previously undergone transurethral resection or enucleation of the prostate.
* Patients who have undergone other abdominal surgery within the last 3 months
* Patients who have visceral metastases
* Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration
* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis
* Severe or active comorbidities likely to impact the advisability of radiotherapy
* Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patient
* Patients who have participated in other clinical trials within the last 3 months
* Patients who refuse to undergo RALP
* Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05707468
Study Brief:
Protocol Section:
NCT05707468