Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Prostatectomy, Chemohormonal therapy, Androgen deprivation therapy, docetaxel chemotherapy Read More

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate without signet cell or small cell features.
• High risk prostate cancer defined as extracapsular extension (cT3a) or seminal vesicle involvement (cT3b) or invasion of adjacent structures (cT4), serum PSA greater than 20 ng/mL or Gleason score of 8 to 10 and/or regional lymph node or

• Oligometastatic disease defined as disseminated metastases beyond regional lymph nodes that meet the following criteria:

  • No visceral metastases
  • Less than four bony metastases.
• Ability to comply with all study procedures and willingness to remain supine for 120 minutes during imaging.
• Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
• Patients must be considered candidates for prostatectomy as per standard of care.

• Adequate hematologic and renal function as evidenced by the following within 4 weeks of day 1:

  • ANC greater than or equal to 1500/mm3
  • Hemoglobin (HgB) greater than or equal to 10.0 gr/dL independent of transfusion
  • Platelets greater than or equal to 100,000/mm3
  • Creatinine less than or equal to 2.0 mg/dL
  • Total bilirubin less than or equal to Upper Limit of Normal (ULN)
• Estimated life expectancy of greater than or equal to 12 months at screening.

• Throughout the study, patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) from screening through 3 months after last dose of study drug. Two acceptable methods of birth control thus include the following:

  • A condom (barrier method of contraception) AND One of the following is required:
  • Established and ongoing use of oral, injected, or implanted hormonal method of contraception by the female partner
  • Placement of an intrauterine device or intrauterine system by the female partner
  • Additional barrier method: Contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner
  • Tubal ligation in the female partner performed at least 6 months before screening
  • Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), performed at least 6 months before screening
• While receiving chemotherapy, the patient must use a condom if having sex with a pregnant woman.
• Must agree not to donate sperm from first dose of study drug through 3 months after the last dose of study drug.

Exclusion Criteria:

• Prior treatment for prostate cancer, including ADT, orchiectomy, antiandrogens, ketoconazole, abiraterone acetate or enzalutamide.
• Prior radiation to the prostate.
• Use of other investigational agent for prostate cancer.
• No active secondary malignancy

• Chronic liver disease or abnormal liver function:

  • Total bilirubin greater than ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is greater than ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
  • Alanine (ALT) or aspartate (AST) aminotransferase greater than 2.0 x ULN or
  • ALT or aspartate AST greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN.
• Peripheral neuropathy grade greater than 1.
• Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within the previous 6 months.
• Major surgery within 4 weeks before screening.
• Patients with known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.
• Herbal supplements that have been shown to modulate testosterone or androgen signaling (e.g. Saw Palmetto) are not allowed while on study.
• Subjects may not be enrolled concurrently on other treatment studies. Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator or medical monitor.

• Subjects who will be receiving Ferumoxytol MRI tracer must:

  • Not have any known hypersensitivity to Feraheme or any of its components
  • Must not have a history of allergic reaction to any intravenous iron product.
  • Must not have a known iron overload (based on medical history)