๐ฌIn plain words
What the trial is, and whether it could suit you
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Must have histologically confirmed prostate cancer.
2. Age โฅ 18 years.
3. ECOG performance status of 0-1.
4. Must have the ability to understand and the willingness to sign a written informed consent document.
5. Willing to provide serial blood samples for the study.
6. Willing to provide tumor tissue (prostatectomy for primary cohort; prostatectomy or biopsy for exploratory cohort) for correlative studies which will compare ctDNA to tumor specimens.
7. Primary Cohort: High-risk localized prostate adenocarcinoma defined as one or more of the following:
o Clinical stage โฅ cT3a, Grade Group 4 or 5 (Gleason sum 8-10), and PSA โฅ 20
\*Non-bulky pelvic lymphadenopathy and indeterminate findings on staging imaging (CT, bone scan, PSMA PET CT) are allowed if the surgeon believes RP is appropriate.
8. Exploratory Cohort: Men with a diagnosis of prostate adenocarcinoma and one of the following:
* Localized prostate adenocarcinoma on active surveillance
* Biochemically-recurrent prostate adenocarcinoma after definitive local therapy
* Hormone-sensitive, metastatic prostate adenocarcinoma
* Metastatic CRPC
Exclusion Criteria:
1. History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.
2. Receiving androgen deprivation or other systemic therapy for prostate cancer.
3. Medical condition or social situation that may preclude adherence to the protocol.
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UPMC Hillman Cancer Center
Pittsburgh, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.