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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07426094
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate.
* Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease.
* Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and/or PSMA PET/CT.
* No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.
* Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes.
* Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy.
* Age ≥18 years.
* Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
* Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases.
* Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy.
* Prior pelvic radiotherapy for any indication that would overlap planned treatment fields.
* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy.
* History of castration-resistant prostate cancer.
* Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes.
* Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy.
* Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07426094
Study Brief:
Protocol Section:
NCT07426094