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

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02494713

Run by

The University of Texas Health Science Center, Houston

People needed

4

Starts

2015-10-01

Expected to finish

2017-09-14

Last updated by the study team

2018-11-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UTHealth Memorial Hermann Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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