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Protocol No. UW17009

Principal Investigator Kyriakopoulos, Christos

Phase Pilot/Feasibility

Age Group Adult

Scope Local

Sponsor Type Externally Peer-Reviewed; Institutional

Title Pilot neoadjuvant trial of chemohormonal therapy followed by prostatectomy in patients with high risk and oligometastatic prostate cancer

Objective The main purpose of this study is to evaluate a new way of treating patients with prostate cancer. Patients who have high risk prostate cancer that has not spread are routinely treated with surgery or radiation with the possible addition of hormonal therapy. Patients in whom the cancer has spread outside the prostate are routinely treated with hormonal therapy alone or in combination with chemotherapy. In this study, we want to see if there is a benefit for starting treatment with combined chemotherapy and hormonal therapy before surgery so we can increase the chance of all the signs of the disease disappearing by the time you undergo surgery. In addition we are evaluating PSMA PET/CT and PET/MRI imaging as a way to see what happens to the cancer after the study treatment. We are also looking at circulating tumor cells in the blood and genetic information in tumor tissue and comparing those results with the imaging and PSA results

Treatment Patients will receive up to 3 doses of degarelix at 4-5 week intervals. This is an injection under the skin that takes a few seconds to administer. For the first dose patients will receive 2 injections. For the second and third doses patients will receive one injection. In addition to receiving the degarelix injections, patients will take bicalutamide (Casodex) as a tablet once every day for about 14 weeks, starting on the same day they receive the first dose of degarelix and continuing until their surgery to remove their prostate. Patients will start taking the bicalutamide (Casodex) and receive their first injection of degarelix 2 weeks before they start the docetaxel chemotherapy. The docetaxel is an infusion received via an intravenous (IV) catheter once every three weeks. Each three-week period is called a chemotherapy cycle. Patients will have up to three cycles of Docetaxel in total. After this is all completed then patients will get a prostatectomy(surgery to remove the prostate).

Description Open-label, pilot, single-arm study for patients with high risk localized or oligometastatic disease using docetaxel chemotherapy, androgen-deprivation therapy(casodex and degarelix) followed by prostatectomy

Key Eligibility
  • Age 18 years or older
  • 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 >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
  • 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 IRB-approved written informed consent form indicating such an understanding
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients must be considered candidates for prostatectomy as per standard of care.
  • Adequate hematologic, liver and renal function
  • Estimated life expectancy of ≥ 12 months
  • Throughout the study, patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control
  • No prior treatment for prostate cancer, including ADT, orchiectomy, antiandrogens,ketoconazole, abiraterone acetate or enzalutamide, radiation therapy, use of investigational agents for prostate cancer
  • No active secondary malignancy
  • No peripheral neuropathy grade >1.
  • No active cardiac disease
  • No herbal supplements that have been shown to modulate testosterone or androgen signaling (e.g. Saw Palmetto)
  • 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

  • Applicable Disease Sites Prostate

    Status Open

    Participating Institutions UW Hospital and Clinics