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

Primary Purpose

Metastatic Cancer, Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

antiandrogen therapy

zoledronic acid

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring bone metastases, stage IV prostate cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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)
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

Exclusion criteria:

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

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

Sites / Locations

Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.

Patients receive maximum androgen-blockade therapy for up to 24 courses.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Overall survival

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

Extent of disease on bone scan (EOD)

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

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.

FACES pain-rating scale

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

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.

QOL (SF-36)

Rantision of QOL health survey scale durintg protocol treatment.

Full Information

NCT ID

NCT00685646

First Posted

May 22, 2008

Last Updated

October 15, 2015

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Kyoto University, Graduate School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00685646

Brief Title

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

Acronym

ZAPCA

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Kyoto University, Graduate School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer, Prostate Cancer

Keywords

bone metastases, stage IV prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

227 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.

Arm Title

Arm II

Arm Type

Active Comparator

Arm Description

Patients receive maximum androgen-blockade therapy for up to 24 courses.

Intervention Type

Drug

Intervention Name(s)

antiandrogen therapy

Intervention Description

Up to 24 courses of therapy

Intervention Type

Drug

Intervention Name(s)

zoledronic acid

Intervention Description

Up to 24 courses of therapy

Primary Outcome Measure Information:

Title

Time to treatment failure (TTF)

Description

Time Frame

6 years

Secondary Outcome Measure Information:

Title

Time to first skeletal-related events (SRE)

Description

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.

Time Frame

6 years

Title

Overall survival

Description

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

Time Frame

6 years

Title

Extent of disease on bone scan (EOD)

Description

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

Time Frame

Baseline, Month 12, 24 and 36

Title

Pain scale

Description

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.

Time Frame

Baseline, Month 12, 24 and 36

Title

FACES pain-rating scale

Description

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

Time Frame

Baseline, Month 12, 24 and 36

Title

Adverse events

Description

Time Frame

Month 6, 12, 18, 24 and 30

Title

QOL (SF-36)

Description

Rantision of QOL health survey scale durintg protocol treatment.

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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 Exclusion criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osamu Ogawa, MD, Ph.D.

Organizational Affiliation

Kyoto University, Graduate School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyoto University Hospital

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

33270906

Citation

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.

Results Reference

derived

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

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