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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT04746300
Eligibility Criteria:
Inclusion Criteria:
1. Male aged 18 or older with adenocarcinoma of the prostate defined by: Documented histopathology at diagnosis of prostate adenocarcinoma without evidence of predominant or primary neuroendocrine histology.
2. Patients with a metastatic tumor site accessible for image-guided biopsy and allowing research analyses for this trial (e.g. biomarker testing by genomic, proteomic or transcriptomic assessment). A waiver can be made for patients presenting with metastatic hormone-sensitive prostate cancer (mHSPC), and no easily accessible tumour for biopsy and suitable primary tissue available for NGS.
3. Castration-resistant state (defined as disease progressing despite \[chemical\] castration per PCWG3 criteria)
4. Progressive disease as either
* A rising PSA on minimum 2 serial consecutive measurements
* Radiographic soft tissue progression per RECIST1.1 or bone progression per PCWG3 criteria
* Clinical progression
5. At least one metastatic lesion present at baseline CT, MRI, 68Ga/18F-PSMA PET or bone scan
6. ECOG Performance status 0 to 2
7. Serum testosterone on castration level
8. Adequate renal function:
• MDRD-GFR ≥ 30 ml/min/1.73m2
9. Adequate bone marrow function:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x109/L
* Hemoglobin (Hb) ≥ 5.6 mmol/L
10. Adequate liver function:
* Total bilirubin level ≤ 2 institutional upper limit of the normal (ULN)
* Aspartate aminotransferase (ASAT) ≤ 3 x ULN (or ≤ 5x ULN in case of known liver metastases)
* Alanine aminotransferase (ALAT) ≤ 3 x ULN (or ≤ 5x ULN in case of known liver metastases)
11. Estimated life expectancy \> 12 months
12. Willing and able to comply to the research protocol
13. Signed, written informed consent
Exclusion Criteria:
1. Prior chemotherapy and androgen receptor inhibition therapy related to castration resistant prostate cancer (one line of chemotherapy or androgen receptor inhibition may be given in the hormone-sensitive setting)
2. Active malignancy other than prostate cancer, except for patients with basal or squamous skin cancer. A waiver may be obtained from the PI in cases where the active malignancy is indolent and believed not to reduce mortality.
3. Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI).
4. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
5. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
6. Any condition which, in the opinion of the investigator, would preclude participation in this observational study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04746300
Study Brief:
Protocol Section:
NCT04746300