Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Velcade; Drug: LH-RH Agonist; Drug: Androgen Receptor Antagonists

• Registration Number: NCT00103376
• Lead Sponsor: Medical University of South Carolina

Brief Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-02-07
• Study First Submitted QC: 2005-02-07
• Study First Posted: 2005-02-08
• Primary Completion: 2009-10
• Study Completion: 2011-06
• Results First Submitted: 2018-05-04
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Results First Posted: 2018-11-05
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist	Velcade	Patient will start Part B after completing Part A or may be enrolled to part B only.
Part A: Velcade	Velcade	Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Part B (Velcade + antiandrogen). If the patient has a partial response or stable disease, he will start Part B after at least a 7-day break.
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist	Androgen Receptor Antagonists	Patient will start Part B after completing Part A or may be enrolled to part B only.
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist	LH-RH Agonist	Patient will start Part B after completing Part A or may be enrolled to part B only.

Primary Outcome Measures

Name	Time	Method
Prostate-specific Antigen (PSA) Response	3 months after the start of treatment
Time to PSA Progression	From on study until time of PSA progression for up to two years	PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of \>= 1.0 ng/ml.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0	From start of treatment until end of study, up to 6 months
Disease-free Interval	3 months after combined treatment	This will only be analyzed if sample size warrants the analysis.

Trial Locations

Locations (4)

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

South Carolina Oncology Associates, PA; 🇺🇸 Columbia, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States