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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT03556904
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have biopsy-confirmed adenocarcinoma of the prostate
* Subjects must discontinue any prior systemic therapies (excluding GnRH agonist/antagonists) without PSA withdrawal effects if using first generation anti-androgens. Luteinizing hormone-releasing hormone (LHRH) analogues must be continued if they have not undergone orchiectomy. (Subjects who recently started systemic therapy for metastatic castration-resistant prostate cancer (mCRPC) are eligible to enroll if new therapy was started ≤ 14 days to consent date.)
* Subjects must have progressive metastatic castration-resistant prostate cancer based on at least one of the following criteria while having castrate levels (\<50 ng/dL) of testosterone:
* A) PSA progression defined as a 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval.
* B) Progression of bidimensionally measurable soft tissue or nodal metastasis by CT scan or MRI based on RECIST criteria
* C) Progression of bone disease on bone scan as defined by two new lesions arising
* Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5 treatment sites that can be treated within a radiotherapy treatment field.
* Subjects must be medically fit to undergo radiotherapy and systemic therapy as determined by the treating physician.
* Age ≥ 18
* ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
* No prior invasive malignancy in the past 3-years. Exceptions include non-melanomatous skin cancer and in situ cancers of the bladder or head and neck are permissible.
* Subjects must freely sign informed consent to enroll in the study.
* Subjects must use contraception up to 90 days after last drug dose.
Exclusion Criteria:
* Planned systemic therapy with Radium-223 dichloride or sipuleucel-T
* Tumor requiring emergent radiation in view of provider
* Life expectancy estimate of \<3 months
* Presence of known parenchymal brain metastasis
* Uncontrolled intercurrent illness
* Inability to undergo radiotherapy, systemic treatment, CTs or bone scans
* Biopsy proven pure small cell or neuroendocrine prostate cancer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03556904
Study Brief:
Protocol Section:
NCT03556904