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Active Not Recruiting
NCT04126070
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
Conditions: Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma, Metastasis Prostate Adenocarcinoma
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 47
Sponsor: Xiao X. Wei, MD
Location: University of California, San Diego La Jolla California
Summary
This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are:
* Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon).
* Docetaxel
* Nivolumab
Eligibility Criteria
Inclusion Criteria:
* Newly diagnosed histologically confirmed prostate adenocarcinoma within 6 months prior to study registration with evidence of high-volume distant metastasis on conventional imaging
* Distant metastasis is defined by non-regional lymph node(s) metastasis (M1a), bone metastasis (M1b), and/or other site(s) of metastatic disease (M1c).
* Conventional imaging consists of CT, MRI or radionuclide bone scan
* High volume of disease is defined by presence of four or more bone lesions with at least one beyond the vertebral bodies or pelvis or any site of visceral metastasis.
* Age ≥18 years
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Subjects with ECOG performance status of 2 are only eligible if the performance status decline is attributed to metastatic prostate cancer
* Serum PSA \> 4.0 ng/mL before initiation of ADT
* Serum testosterone \> 100 ng/dL before initiation of ADT
* Subjects whose testosterone level is unknown before initiation of ADT may be allowed after discussion with Sponsor-Investigator.
* Grade ≤ 1 peripheral neuropathy, defined as asymptomatic or paresthesia and/or decreased deep tendon reflexes is allowed.
* Subjects must have adequate organ and marrow function as defined below:
* Absolute neutrophil count ≥1,500 /mcL
* Platelets ≥100,000 /mcL
* Total bilirubin ≤1.5 × institutional upper limit of normal. Exception: Subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology) may be allowed after consultation with treating physician
* AST(SGOT) and ALT(SGPT) ≤2.5 × institutional upper limit of normal. Exception: ≤5 x institutional upper limit of normal in subjects with liver metastasis
* Creatinine (Cr) and creatinine clearance (CrCl) Cr \
Source: ClinicalTrials.gov (NCT04126070). StuddyBuddy aggregates publicly available trial information.