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Metastatic CancerPhase 3ZAPCANCT00685646

Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases

A Phase 3 study testing antiandrogen therapy and zoledronic acid in people with Metastatic Cancer and Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of the symptoms caused by bone metastasis. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Metastatic Cancer, Prostate Cancer
What is being tested?
antiandrogen therapy and zoledronic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
1 siteJapan
Study dates
May 2008to Jan 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with definitive diagnosis of prostatic cancer by histopathological diagnosis or cytology
  • Androgen blockade therapy-, systemic chemotherapy-, bisphosphonates-naïve prostatic cancer patients
  • Patients who are sensitive to androgen blockade therapy
  • Patients with bone metastasis on bone scan (EOD ≥ 1)
  • Patients who have Eastern Cooperative Oncology Group performance status (ECOG: 0-2)
  • Patients who have prostate-specific antigen performance status (PSA ≧30 ng/mL)
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  • Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration.
  • Leukocyte count ≥ 3,000/μL
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 7.5 × 10^4/μL
  • Serum creatine level ≤ 3.0 mg/dL
  • 8.5 mg/dL ≤ corrected serum level of calcium ≤ 11.5 mg/dL
  • Total bilirubin ≤ 1.8 mg/dL
  • Aspartate aminotransferase (AST) Levels ≤ 90 IU/L
  • Alanine aminotransferase (ALT) Levels ≤ 100 IU/L
  • Patients who agreed to participate in this clinical study in writing after receiving sufficient explanation

Who cannot join

  • Patients with poorly-controlled dental caries
  • Patients with double cancer that requires treatment
  • Patients who are using following steroid drugs (except for topical ointment)
  • Patients with poorly-controlled hypertension or cardiovascular disease
  • Patients with active infectious diseases or HIV or hepatitis virus infections
  • Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator
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  • PRIOR CONCURRENT THERAPY:
  • No prior androgen-blockade therapy
  • No prior or other concurrent anticancer therapy
  • No prior or concurrent immunologic adjuvant therapy
  • No prior or concurrent steroid drugs (except ointment)
  • No other prior or concurrent bisphosphonates (excluding zoledronic acid)
  • No prior systemic chemotherapy

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

Other trials in Japan

About this study

Official title: A Phase III, Multicenter, Randomized, Controlled Study of Maximum Androgen Blockade With vs. Without Zoledronic Acid in Prostatic Cancer Patients With Metastatic Bone Disease

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of the symptoms caused by bone metastasis. It is not yet known whether androgen-blockade therapy is more effective with or without zoledronic acid in treating patients with prostate cancer that has spread to the bone.

PURPOSE: This randomized phase III trial is studying androgen-blockade therapy given together with zoledronic acid to see how well it works compared with androgen-blockade therapy alone in treating patients with prostate cancer and bone metastases.

Read the detailed description

OBJECTIVES:

  • Evaluate the time to treatment failure in prostatic cancer patients with metastatic bone disease receiving maximum androgen-blockade therapy with vs without zoledronic acid.
  • Evaluate the time to first skeletal-related events in these patients.
  • Evaluate the overall survival of these patients.
  • Evaluate the extent of disease on bone scan in these patients.
  • Evaluate the pain scale and FACES pain-rating scale in these patients.
  • Evaluate the safety of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive maximum androgen-blockade therapy for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Being tested
antiandrogen therapy, zoledronic acid
Keywords
bone metastases, stage IV prostate cancer
Medical subject headings
Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

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

  • antiandrogen therapyDrug

    Up to 24 courses of therapy

  • zoledronic acidDrug

    Up to 24 courses of therapy

Study groups in NCT00685646
Study groupRoleWhat they receive
Arm IExperimentalPatients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.
Receives: Drug: antiandrogen therapy; Drug: zoledronic acid
Arm IIActive comparatorPatients receive maximum androgen-blockade therapy for up to 24 courses.
Receives: Drug: antiandrogen therapy

What is being measured

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

  1. Time to treatment failure (TTF)

    The interval from the date of randomization to the earliest date on which prostate-specific antigen (PSA) progression, clinical progression, first skeletal-related events (SRE), death, or cessation of protocol treatment for any reason occurred.

    Measured: 6 years

Secondary outcomes (7)

  1. Time to first skeletal-related events (SRE)

    The interval from the date of randomization to the earliest date of the first SRE or death for any reason. But exlude tha another SRE existing case on the same region as of the randomization.

    Measured: 6 years

  2. Overall survival

    The interval from the date of randomization to death for any reason.

    Measured: 6 years

  3. Extent of disease on bone scan (EOD)

    Ransition of EOD bone scan grade at randomization, 12, 24, 36 months after the therapy.

    Measured: Baseline, Month 12, 24 and 36

  4. Pain scale

    Ransition of with/without narcotic drug usage at randomization, 12, 24, 36 months after the therapy and if the case of without usage, ransition of rest pain scale.

    Measured: Baseline, Month 12, 24 and 36

  5. FACES pain-rating scale

    Ransition of FACES pain-rating scale at randomization, 12, 24, 36 months after the therapy.

    Measured: Baseline, Month 12, 24 and 36

  6. Adverse events

    Adverse events from date of starting protocol treatment until 28 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.

    Measured: Month 6, 12, 18, 24 and 30

  7. QOL (SF-36)

    Rantision of QOL health survey scale durintg protocol treatment.

    Measured: Month 6, 12, 18, 24, 30 and 36

Timeline

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

  1. First posted28 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJan 2014
  4. Study completionJan 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00685646
Sponsor's protocol ID
TRIGU0705
Other IDs
KYUH-TRIGU0705
Acronym
ZAPCA
Status last verified
Oct 2015
First submitted
22 May 2008
Last updated
16 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.

    PubMed 33270906

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing antiandrogen therapy and zoledronic acid in people with Metastatic Cancer and Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

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

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to treatment failure (TTF) (time frame: 6 years). 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 NCT00685646, which also lists 1 linked publication.

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 16 Oct 2015.

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