Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Androgen Antagonists; Androgens; Ascorbic Acid; Docetaxel; Estrogens, Conjugated (USP); Hormones; Methyltestosterone

Criteria

Inclusion Criteria:

• Histologically proven adenocarcinoma of the prostate

• Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation

• Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.

• If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)

• No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)

• Give informed consent

• Prostate deemed resectable by surgeon

• Plans to start or has already started antiandrogen therapy (ADT) no longer than 6 months prior to consent

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Hemoglobin (HgB) >= 9 g/dL compatible for surgery

• Platelets > 80,000/mcL compatible for surgery

• Aspartate aminotransferase (AST) =< 2x upper limit of normal (ULN) compatible for surgery

• Alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery

Exclusion Criteria:

• Refuses to give informed consent

• Deemed to have unresectable disease by surgeon

• Received ADT for more than 6 months prior to consent

• Life expectancy of less than 6 months prior to consent

• Known spinal cord compression

• Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent

• Previous local therapy for prostate cancer

• Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent