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Clinical Trial 19367

Cancer Type: Genitourinary
Interventions:ADT; Abiraterone acetate; Bicalutamide; Casodex (Bicalutamide); Zytiga (Abiraterone acetate); prednisone

Study Type: Treatment
Phase of Study: Early Phase I
Investigators:

  • Jingsong Zhang

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Pilot Study Of Intermittent Androgen Deprivation Therapy Adapted To Serum Testosterone And PSA Levels For Stage IV Castration Sensitive Prostate Cancer

Summary

The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).

Objective

Exploratory objectives/correlative studies: Detect the intra-tumor heterogeneity of AR and Cyp17 IHC stains on FFPE blocks of primary prostate cancer and or metastatic lesions. Refine the mathematical model for adaptive ADT. To develop imaging habitat biomarkers to track diseases progression using the patients scans and compare with conventional progression variables (like PSA). Compare the AR, Cyp17 IHC stains as well as imaging biomarkers with a retrospective cohort of mCSPC patients who underwent continuous ADT as standard of care.

Inclusion Criteria

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • High risk mCSPC as defined by the Latitude study5 (≥ 2 of 3 risk factors: Gleason ≥ 8, ≥ 3 bone lesions, or measurable visceral metastases)
  • Patients with >75% prostate specific antigen (PSA) decline after 12 weeks of run in period with androgen deprivation therapy (ADT), abiraterone plus prednisone.
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
  • Adequate organ function Serum alanine aminotransferase (ALT) or aspirate aminotransferase (AST) must be 40 mL/min, absolute neutrophil count (ANC) > 1500/l, hemoglobin above 9 g/dl, platelet count > 100,000/l
  • Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
  • Ability to give written informed consent

  • Exclusion Criteria

  • Prior ADT with GnRH analogue for non-metastatic prostate cancer within 2 years prior to study enrollment; or > 3 months of GnRH analog in the metastatic setting.
  • Prior treatments with TAK-700/Orteronel, abiraterone, ketoconazole, apalutamide or enzalutamide.
  • Documented central nervous system metastases or liver metastasis
  • Prior surgical castration.
  • Requiring opioids for cancer related pain.
  • Treatment with any investigational compound within 30 days prior to the first dose of study drugs
  • Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy & have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Uncontrolled hypertension despite appropriate medical therapy (blood pressure of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening period). Note: Patients may be rescreened after adjustments of antihypertensive medications
  • Unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 5), New York Association Class III or IV heart failure
  • Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study.
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of study drugs, including difficulty swallowing tables.
  • Delayed healing of wounds, ulcers, and/or bone fractures
  • Inability to comply with protocol requirements