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Prostate CancerPhase 2NCT00103376

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

A Phase 2 study testing Velcade, LH-RH Agonist and Androgen Receptor Antagonists in people with Prostate Cancer, run by Medical University of South Carolina at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Velcade, LH-RH Agonist and Androgen Receptor Antagonists
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
4 sitesUnited States
Study dates
Oct 2004to Jun 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

Other trials in United States

About this study

Official title: VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer

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.

Conditions
Prostate Cancer
Being tested
Velcade, LH-RH Agonist, Androgen Receptor Antagonists
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VelcadeDrug

    Also called bortezomib

    Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.

    Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break

  • LH-RH AgonistDrug

    given as a 3 month depo-injection

  • Androgen Receptor AntagonistsDrug

    given orally daily for 3 months

Study groups in NCT00103376
Study groupRoleWhat they receive
Part A: VelcadeExperimentalPatient 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.
Receives: Drug: Velcade
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonistExperimentalPatient will start Part B after completing Part A or may be enrolled to part B only.
Receives: Drug: Velcade; Drug: LH-RH Agonist; Drug: Androgen Receptor Antagonists

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate-specific Antigen (PSA) Response

    Measured: 3 months after the start of treatment

  2. Time to PSA Progression

    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.

    Measured: From on study until time of PSA progression for up to two years

Secondary outcomes (2)

  1. Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0

    Measured: From start of treatment until end of study, up to 6 months

  2. Disease-free Interval

    This will only be analyzed if sample size warrants the analysis.

    Measured: 3 months after combined treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionOct 2009
  4. Study completionJun 2011

Why it stopped: Low Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103376
Sponsor's protocol ID
CDR0000406013
Other IDs
MUSC-031218, MUSC-HR-11357
Status last verified
Oct 2018
First submitted
7 Feb 2005
Last updated
5 Nov 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Velcade, LH-RH Agonist and Androgen Receptor Antagonists in people with Prostate Cancer, run by Medical University of South Carolina at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate-specific Antigen (PSA) Response (time frame: 3 months after the start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00103376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.

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