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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103376
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : April 30, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bicalutamide Drug: bortezomib Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Phase 2

Detailed Description:



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


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

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
Study Start Date : October 2004
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Bortezomib
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Safety as assessed by Common Toxicity Criteria, medical history, physical exams, and lab values weekly after combined treatment
  2. Disease-free interval assessed 3 months after combined treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • At least 1 year


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


  • No known hepatitis B or C positivity


  • Creatinine clearance ≥ 30 mL/min


  • 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


  • 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


Biologic therapy

  • Not specified


  • 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


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


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103376

United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Medical University of South Carolina
Principal Investigator: Andrew S. Kraft, MD Medical University of South Carolina

Responsible Party: Andrew S. Kraft, Hollings Cancer Center at Medical University of South Carolina Identifier: NCT00103376     History of Changes
Other Study ID Numbers: CDR0000406013
First Posted: February 8, 2005    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Medical University of South Carolina:
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists