PS-341 Followed by Removal of Prostate for Those With Prostate Cancer

NCT00425503 | Completed Phase 2 Results

• 2 other identifiers: H-11047P50CA058204
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Following pretreatment evaluation, patients receive PS-341 by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest period. This schedule consists of one treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest period, radical prostatectomy will be performed. Surgery will be delayed if there is any bleeding abnormality (bleeding time greater than 10 minutes) and until platelet count is more than or equal to 100,000 and coagulation profile (PT, PTT) is normal. If at the time of surgery a patient is found to have positive lymph nodes, prostatectomy will be abandoned, the prostate will be biopsied, and the patient will be offered other treatment modalities (hormones, radiation therapy).

Conditions

Prostate Neoplasms

Keywords

Prostate Cancer; Bortezomib; Radical Prostatectomy; Phase 2 Clinical Trial

Outcome Measures

Primary Outcomes (1)

• The Purpose of the Present Study is to Assess the Safety of PS-341 as a Pretreatment in Patients Who Are to Undergo a Radical Prostatectomy. Poor Wound Healing and Excessive Bleeding, With Historical Rates of <1% and 10% Respectively Will be Measured.

  Pour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.

  Poor wound healing (dehiscence of fascia during the first postoperative week) and bleeding 24 hours after surgery

Interventions

PS-341 (bortezomib) DRUG

PS-341 is a dipeptidyl boronic acid inhibitor with high specificity for the proteasome developed by Millennium Pharmaceuticals Inc. to treat human malignancies. It is the first member of this class of anti-tumor agents to come to human trials. Patients will receive PS-341 (1.6mg/m2/dose) by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest. This schedule consists of one treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest period, radical prostatectomy will be performed.

Also known as: bortezomib, VELCADE™

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1, T2 or T3 with high grade disease (Gleason's grade 7 or above).
• Recent (less than or equal to 6 weeks prior to study entry) negative bone scan and CT scan of abdomen/pelvis.
• Appropriate surgical candidate for radical prostatectomy and a performance status of less than or equal to 2 (Zubrod scale).
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count greater than or equal to 1,500 and platelet count of greater than or equal to 100,000, adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and SGPT less than 2.5x the upper limits of normal, adequate renal function defined as serum creatinine less than or equal to 2.0 mg %.
• Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution.
• Patients screened and found eligible for the study, but not wanting to participate for any reason, will be followed along with the patients enrolled in the study in an effort to obtain outcome information (as historical information for design of future trials).
• No evidence of bifascicular block or active ischemia on EKG.
• Patients must have no history of congestive heart failure or previous MI.

You may not qualify if:

• Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
• Unable to tolerate transrectal ultrasound.
• Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible.
• Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.
• Patients on steroid medications are not eligible.
• Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
• Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass, claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible.
• Patients with diabetes mellitus requiring insulin or oral hypoglycemics for more than 5 years are not eligible.
• Patient has greater than or equal to grade 1 peripheral neuropathy within 14 days before enrollment.
• Hypersensitivity to boron, mannitol, or bortezomib.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Scott Department of Urology, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

• Scott Department of Urology Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Teresa Hayes - Associate Professor
• Organization: Baylor College of Medicine

thayes@bcm.edu

713-794-7368

Study Officials

• Teresa Hayes, M.D., Ph.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: December 1, 2001
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 21, 2014
• Results First Posted: April 1, 2014

Record last verified: 2014-04

Locations

US (1)