Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

ECOG 0-1

Life expectancy

At least 1 year

Hematopoietic

Platelet count ≥ 30,000/mm^3
Absolute neutrophil count ≥ 1,000/mm^3

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

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

23

Study ID:

NCT00103376

Recruitment Status:

Terminated

Sponsor:

Medical University of South Carolina

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There are 4 Locations for this study

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Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda California, 92354, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States
South Carolina Oncology Associates, PA
Columbia South Carolina, 29210, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

23

Study ID:

NCT00103376

Recruitment Status:

Terminated

Sponsor:


Medical University of South Carolina

How clear is this clinincal trial information?

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