Localized or Locally Advanced Prostate CancerNCT03193060

A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer

An observational study of Localized or Locally Advanced Prostate Cancer, run by AstraZeneca at 25 sites in China.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 100 years, men only
Conditions the study is for: Localized or Locally Advanced Prostate Cancer
How many people: 308 participants
Where: 25 sitesChina
Study dates: 19 Sep 2017to 27 Dec 2019
Phase: Observational
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 18 to 100 years
Men only
No healthy volunteers
Adult, Older adult

Study population: The patients with localized or locally advanced prostate cancer who are prescribed Zoladex® (goserelin acetate implant) 10.8 mg or 3.6 mg as monotherapy or in combination with androgen blockade (CAB), either as first line treatment or adjuvant therapy to radical prostatectomy (RP) are eligible to be the study target population.

Who may be able to join

Ability to provide informed consent, complete all study assessments and have complete medical record;
Male aged 18 years and over;
Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;
Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);
More than 26 weeks' life expectancy;

Who cannot join

Patients who are planned to receive radiation therapy;
Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;
Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

China25 sites

Research Site
Beijing, 100034
Research Site
Beijing, 100191
Research Site
Chengdu, 610072
Research Site
Foshan, 528000
Research Site
Guangdong
Research Site
Guangzhou, 510120
Research Site
Guangzhou, 510530
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Jinan, 250012
Research Site
Jinan, 250021
Research Site
Langfang
Research Site
Nanjing, 210009
Research Site
Nanjing, 210029
Research Site
Ningbo, 315000
Research Site
Shanghai, 200032
Research Site
Shanghai, 200433
Research Site
Shijiazhuang
Research Site
Ürümqi, 830054
Research Site
Wuhan, 430022
Research Site
Wuhan, 430060
Research Site
Wuhan, CN-430030
Research Site
Xi'an
Research Site
Yantai, 264000
Research Site
Zhuhai, 519000

Other trials in China

About this study

This study is a multi-centre, prospective observational study. The study plans to enrol 500 patients with localized or locally advanced prostate cancer who are eligible and intended to be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical sites in China. The effectiveness and safety data will be collected at baseline and each visit within 26 weeks after treatment of Zoladex®.

Read the detailed description

Androgen Deprivation Therapy (ADT) is a standard treatment for locally advanced or metastatic prostate cancer. It is also increasingly used in patients with high-risk localized prostate cancer or in patients with prostate-specific antigen (PSA) relapse after local therapy.

The luteinizing hormone-releasing hormone (LHRH) agonists, such as goserelin acetate(Zoladex®), have provided an effective and reversible means of suppressing androgen level. Zoladex® was originally formulated as a 3.6mg depot injection. Goserelin acetate 10.8-mg depot, given once every 3 months, is pharmacodynamically equivalent to 3 consecutive monthly injections of the goserelin acetate 3.6-mg depot, offers a more convenient and cost-effective dosing regimen for patients.

Goserelin acetate 10.8-mg depot has been available in China since 2012. However, data on the effectiveness and safety of the long-acting depot of Zoladex® (goserelin acetate depot) 10.8mg specifically in a Chinese population is limited. A "real-world" observational study is proposed to establish the effectiveness and safety profile of Zoladex ® 10.8mg in Chinese patients with localized or locally advanced prostate cancer.

Conditions: Localized or Locally Advanced Prostate Cancer

What is being measured

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

PSA level
Change from baseline in PSA level at each visit within 26 weeks during treatment
Measured: each visit within 26 weeks during treatment
Serum Testosterone
Change from baseline in the serum Testosterone at each visit within 26 weeks during treatment
Measured: each visit within 26 weeks during treatment

Secondary outcomes (9)

Mean serum Testosterone level
Mean serum Testosterone level at baseline and each visit within 26 weeks during treatment
Measured: each visit within 26 weeks during treatment
Mean serum PSA level
Mean serum PSA level at baseline and each visit within 26 weeks during treatment
Measured: each visit within 26 weeks during treatment
Number of patients with serum Testosterone less than 50 ng/ml
Number of patients with serum Testosterone less than 50 ng/ml at each visit within 26 weeks during treatment
Measured: each visit within 26 weeks during treatment
Incidence of Adverse Events (AEs)
Incidence of Adverse Events (AEs)
Measured: each visit within 26 weeks during treatment
Incidence of AESI (cardiovascular related AE, sexual related AE)
Incidence of AESI (cardiovascular related AE, sexual related AE)
Measured: each visit within 26 weeks during treatment
Incidence of Adverse Drug Reactions (ADRs)
Incidence of Adverse Drug Reactions (ADRs)
Measured: each visit within 26 weeks during treatment
Incidence of AEs leading to treatment discontinuation
Incidence of AEs leading to treatment discontinuation
Measured: each visit within 26 weeks during treatment
Proportion of patients with serum Testosterone less than 50 ng/ml
Proportion of patients with serum Testosterone less than 50 ng/ml at each visit within 26 weeks during treatment
Measured: each visit within 26 weeks during treatment
Incidence of Serious Adverse Events (SAEs)
Incidence of Serious Adverse Events (SAEs)
Measured: each visit within 26 weeks during treatment

Timeline

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

19 Sep 201727 Dec 2019

First posted20 Jun 2017
Study start19 Sep 2017
Primary completion27 Dec 2019
Study completion27 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Localized or Locally Advanced Prostate CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03193060
Sponsor's protocol ID: D8664R00001
Status last verified: Jul 2023
First submitted: 8 May 2017
Last updated: 14 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
Localized Prostate Carcinoma, Locally Advanced Cervical Carcinoma
RecruitingPhase 3
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
Prostate Cancer
Active, not recruitingPhase 3
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
Prostatic Neoplasms
Active, not recruitingPhase 3
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Prostatic Neoplasms
RecruitingPhase 2/3
PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer
Prostate Cancer (Adenocarcinoma), Prostate Brachytherapy

All Localized or Locally Advanced Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer
ClinicalTrials.gov ID: NCT03193060
Acronym / sponsor ID: D8664R00001
Conditions: Localized or Locally Advanced Prostate Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 308 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 19 Sep 2017 (actual)
Primary completion: 27 Dec 2019 (actual)
Study completion: 27 Dec 2019 (actual)
First posted: 20 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective

Who may qualify

Ages: 18 to 100 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The patients with localized or locally advanced prostate cancer who are prescribed Zoladex® (goserelin acetate implant) 10.8 mg or 3.6 mg as monotherapy or in combination with androgen blockade (CAB), either as first line treatment or adjuvant therapy to radical prostatectomy (RP) are eligible to be the study target population.

Key inclusion criteria (5 listed)

Ability to provide informed consent, complete all study assessments and have complete medical record;
Male aged 18 years and over;
Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;
Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);
More than 26 weeks' life expectancy;

Key exclusion criteria (3 listed)

Patients who are planned to receive radiation therapy;
Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;
Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

PSA level
Time frame: each visit within 26 weeks during treatment
Change from baseline in PSA level at each visit within 26 weeks during treatment
Serum Testosterone
Time frame: each visit within 26 weeks during treatment
Change from baseline in the serum Testosterone at each visit within 26 weeks during treatment

9 secondary outcomes

Mean serum Testosterone level
Time frame: each visit within 26 weeks during treatment
Mean serum PSA level
Time frame: each visit within 26 weeks during treatment
Number of patients with serum Testosterone less than 50 ng/ml
Time frame: each visit within 26 weeks during treatment
Incidence of Adverse Events (AEs)
Time frame: each visit within 26 weeks during treatment
Incidence of AESI (cardiovascular related AE, sexual related AE)
Time frame: each visit within 26 weeks during treatment
Incidence of Adverse Drug Reactions (ADRs)
Time frame: each visit within 26 weeks during treatment
Incidence of AEs leading to treatment discontinuation
Time frame: each visit within 26 weeks during treatment
Proportion of patients with serum Testosterone less than 50 ng/ml
Time frame: each visit within 26 weeks during treatment
Incidence of Serious Adverse Events (SAEs)
Time frame: each visit within 26 weeks during treatment

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Localized or Locally Advanced Prostate Cancer

Active, not recruitingPhase 2
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
Localized Prostate Carcinoma, Locally Advanced Cervical Carcinoma
RecruitingPhase 3
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
Prostate Cancer
Active, not recruitingPhase 3
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
Prostatic Neoplasms
Active, not recruitingPhase 3
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Prostatic Neoplasms
RecruitingPhase 2/3
PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer
Prostate Cancer (Adenocarcinoma), Prostate Brachytherapy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Localized or Locally Advanced Prostate Cancer, run by AstraZeneca at 25 sites in China.

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 5 inclusion and 3 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. 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.

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?

PSA level (time frame: each visit within 26 weeks during 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 NCT03193060.

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 14 Jul 2023.