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

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00103376
First received: February 7, 2005
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: bortezomib
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response as measured by complete or partial response, stable or progressive disease 3 months after initial treatment [ Designated as safety issue: No ]
  • Time to PSA relapse as measured by lab tests 3 months after initial treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as assessed by Common Toxicity Criteria, medical history, physical exams, and lab values weekly after combined treatment [ Designated as safety issue: Yes ]
  • Disease-free interval assessed 3 months after combined treatment [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: October 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103376

Locations
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
Investigators
Principal Investigator: Andrew S. Kraft, MD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: Andrew S. Kraft, Hollings Cancer Center at Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00103376     History of Changes
Other Study ID Numbers: CDR0000406013, MUSC-031218, MUSC-HR-11357
Study First Received: February 7, 2005
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Bortezomib
Goserelin
Leuprolide
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014