Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

• Status: Terminated
• Trial end date: 2017-09-14
• Target enrollment: 0
• Participant gender: Male

Summary

This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.

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

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Androgens; Docetaxel; Doxorubicin; Estramustine; Ketoconazole; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Pathologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3. No neuroendocrine differentiation or small cell features.

• Recent (<6 weeks prior to study entry) negative bone scan and CT of the chest and abdomen.

• Appropriate surgical candidate for radical prostatectomy and a performance status of <2 (ECOG scale).

• Adequate bone marrow function as defined as an absolute peripheral granulocyte count >1500 and platelet count >100,000.

• Adequate hepatic function per the following criteria:

• Albumin ≥2.8 g/dL

• AST and ALT ≤5 x ULN

• Total bilirubin <2 mg/dL

• Adequate renal function per the following criteria:

o Serum creatinine ≤1.5 x ULN

• Normal coagulation profile (INR ≤ 1.5, aPTT ≤ 1.5 x ULN for the lab) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).

• Age ≥ 18 years

• Written informed consent to participate in this study.

Exclusion Criteria:

• Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features

• Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first ADT and chemotherapy treatment

• Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or investigational study drug.

• Unable to tolerate multiparametric MRI or is contraindicated.

• Patients not appropriate surgical candidates for radical prostatectomy based on the evaluation of coexistent medical diseases and competing causes of death.

• Patients with uncontrolled cardiac, hepatic, renal, or neurologic/psychiatric disorder.

• Severe gastrointestinal bleeding within 12 weeks of treatment with ADT and chemotherapy

• Patients who are HIV positive or have chronic hepatitis B or C infections.

• Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a 2D echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months of enrollment demonstrates a left ventricular ejection fraction >45%.

• Sensory neuropathy grade >1.

• History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer.

• Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment.

• Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements