Clinical trial NCT03193060: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized or Locally Advanced Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 308
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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®.

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.

Eligibility criteria: Inclusion Criteria:

1. Ability to provide informed consent, complete all study assessments and have complete medical record;
2. Male aged 18 years and over;
3. Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;
4. 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);
5. More than 26 weeks' life expectancy;

Exclusion Criteria:

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

Primary outcomes:
measure: PSA level
timeFrame: each visit within 26 weeks during treatment
measure: Serum Testosterone
timeFrame: each visit within 26 weeks during treatment
Secondary outcomes:
measure: Mean serum Testosterone level
timeFrame: each visit within 26 weeks during treatment
measure: Mean serum PSA level
timeFrame: each visit within 26 weeks during treatment
measure: Number of patients with serum Testosterone less than 50 ng/ml
timeFrame: each visit within 26 weeks during treatment
measure: Incidence of Adverse Events (AEs)
timeFrame: each visit within 26 weeks during treatment
measure: Incidence of AESI (cardiovascular related AE, sexual related AE)
timeFrame: each visit within 26 weeks during treatment
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: each visit within 26 weeks during treatment
measure: Incidence of AEs leading to treatment discontinuation
timeFrame: each visit within 26 weeks during treatment
measure: Proportion of patients with serum Testosterone less than 50 ng/ml
timeFrame: each visit within 26 weeks during treatment
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: each visit within 26 weeks during treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Foshan
country: China
facility: Research Site
city: Guangdong
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Langfang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Urumqi
country: China
facility: Research Site
city: Wu Han
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'An
country: China
facility: Research Site
city: Yantai
country: China
facility: Research Site
city: Zhuhai
country: China
facility: Research Site
Study officials:
References: