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 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT05560659
Eligibility Criteria:
Inclusion Criteria:
1. Male aged 18 years or older at screening
2. Patient has provided written informed consent
3. Histologically confirmed prostate adenocarcinoma w
4. Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
6. Adequate haematological function as defined by:
* Absolute neutrophil count (ANC) ≥1.5 x 109/L
* Platelet count \>150x 109/L
* Haemoglobin ≥100 g/L
* Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
7. Assessed as suitable for SABR by a radiation oncologist
8. Patients must agree to use an adequate method of contraception
9. Have a performance status of 0-1 on the ECOG Performance Scale
Exclusion Criteria:
1. Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal
2. Any visceral (AJCCC M1c) metastases
3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
5. Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05560659
Study Brief:
Protocol Section:
NCT05560659