Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	Other	MUSC-031218 100822, MUSC-HR-11357, NCT00103376

Objectives

Primary

1. Determine the prostate-specific antigen (PSA) relapse after an observed rise in testosterone after combination treatment with hormone blockade and bortezomib.

Secondary

1. Determine the safety of this drug in combination with combined androgen blockade therapy in these patients.
2. Determine the disease-free interval in patients treated with this regimen.
3. Determine time to tsetosterone rise in patients treated wtih this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate



• Relapsed disease after definitive local therapy, as documented only by a rise in prostate-specific antigen (PSA)
  • Experienced PSA relapse after definitive local therapy
  • Rising PSA (≥ 1.0 ng/mL after nadir < 1.0 ng/mL)
    • PSA increase of ≥ 0.3 ng/mL (increase occurred between 2 separate measurements taken ≥ 4 weeks apart)
  • The first of these two PSA values must rise above a previously recorded post-therapy nadir value



• Ineligible for curative therapy



• No clinical evidence of local recurrence (i.e., palpable induration or mass in the prostatic fossa) other than PSA elevation



• No evidence of palpable disease in the prostatic bed



• No metastatic disease (M0)
  • No non-nodal (> N1) metastasis
  • No evidence of osseous metastasis on bone scan within the past 28 days

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• At least 6 months since prior hormonal therapy combined with radiation therapy as definitive therapy
• Neoadjuvant hormonal therapy prior to definitive therapy (e.g., surgery, radiation therapy, brachytherapy, or cryoablation) allowed
• No other concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• More than 12 months since prior radioactive seed therapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• More than 4 weeks since prior surgery
• No concurrent surgery

Other

• No concurrent second-line herbal preparations, including PC-SPES
• No other concurrent investigational agents

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-1

Life expectancy

• At least 1 year

Hematopoietic

• Platelet count ≥ 30,000/mm³
• Absolute neutrophil count ≥ 1,000/mm³

Hepatic

• No known hepatitis B or C positivity

Renal

• Creatinine clearance ≥ 30 mL/min

Immunologic

• No known human T-cell lymphotropic virus positivity
• No hypersensitivity to bortezomib, boron, or mannitol
• No known HIV 1 or 2 positivity
• No active, ongoing bacterial, viral, or fungal infection

Other

• Fertile patients must use effective contraception
• No peripheral neuropathy ≥ grade 2
• No other disease, condition, or social or geographic constraint that would preclude study participation
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

Expected Enrollment

A total of 21-42 patients will be accrued for this study.

Outcomes

Prostate-specific antigen (PSA) response as measured by complete or partial response, stable or progressive disease 3 months after initial treatment
Time to PSA relapse as measured by lab tests 3 months after initial treatment

Safety as assessed by Common Toxicity Criteria, medical history, physical exams, and lab values weekly after combined treatment
Disease-free interval assessed 3 months after combined treatment

Outline

This is an open-label, multicenter study.

Patients receive androgen blockade therapy comprising a 3-month subcutaneous injection of goserelin OR leuprolide OR other FDA-approved method of primary androgen suppression AND oral flutamide or bicalutamide once daily for 3 months. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment with bortezomib repeats every 28 days for 3 courses. Patients achieving a CR discontinue treatment and are observed for PSA or metastatic disease recurrence. Patients with a PR or stable disease receive additional combined androgen blockade therapy and 3 additional courses of bortezomib as above. Patients with progressive disease are removed from the study.

Patients are followed every 3 months for up to 5 years.

Trial Contact Information

Trial Lead Organizations

Hollings Cancer Center at Medical University of South Carolina

Andrew Kraft, MD, Principal investigator		Ph: 843-792-9321

U.S.A.
California
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Andrew Kraft, MD	Ph:  843-792-9321
	Columbia
	South Carolina Oncology Associates, PA
		William Butler, MD	Ph:  803-461-3708
			Email: wbutler@sconcology.net
	Spartanburg
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941

Registry Information
Official Title		VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
Trial Start Date		2004-10-25
Trial Completion Date		2010-10-25 (estimated)
Registered in ClinicalTrials.gov		NCT00103376
Date Submitted to PDQ		2004-11-08
Information Last Verified		2009-06-14

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