A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.

NCT03971110 | Terminated Phase 4

• 1 other identifier: D8664C09827
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 15

Brief Summary

This is A Multi-centre, Single-arm, Prospective, Interventional Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients with Advanced Prostate Cancer Undergoing Radical Prostatectomy, to assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer.

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Resectability rate for primary tumour (the resectability will be assessed by central review using a digital rectal examination and confirmed by CT or MRI)

  To assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer

  at 24 week

Secondary Outcomes (11)

• Radical prostatectomy rate

  From baseline to 24 week

• The mean PSA by the end of NHT

  From baseline to 24 week

• Percentage of positive surgical margin for primary tumour

  From baseline to 24 week

• Incidence of seminal vesicle invasion

  From baseline to 24 week.

• Percentage of pathological downstaging

  From baseline to 24 week

Study Arms (1)

Zoladex and Casodex

EXPERIMENTAL

Subjects who are diagnosed with advanced prostate cancer at clinical stage of T3 and T4 (N0 or N1, M0 or M1 with five or fewer extra-pelvic lesions) are the target population of this study. The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously as neoadjuvant therapy per 12 weeks for up to 24 weeks.

Drug: Zoladex and Casodex

Interventions

Zoladex and Casodex DRUG

The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously as neoadjuvant therapy per 12 weeks for up to 24 weeks.

Zoladex and Casodex

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed within the past 12 months with T2DM according to 1999 WHO criteria
• Men and women aged at least 18 years at screening.
• Either not received oral anti-diabetic drugs or had been on short-term (1 month) treatment that had been discontinued 3 months before enrolment.
• HbA1c ≥ 7.5% and ≤ 10.5% at screening and HbA1c ≥ 7.0% and ≤ 10.5% at pre-randomization visit.
• FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) .
• BMI≥18.5 kg/m2 and ≤ 45.0 kg/m2 .
• C-peptide ≥0.33nmol/L(≥1.0 ng/mL).
• Able and willing to provide written informed consent and to comply with the study.

You may not qualify if:

• Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
• Diagnosis or history of:
• Acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state
• Diabetes insipidus.
• Requirement for insulin therapy. Symptoms of poorly controlled diabetes, including but not limited to, marked polyuria and polydipsia with \>10% weight loss during the 3 months before enrollment.
• Triglycerides (fasting) \> 9.3 mmol/L (\> 800 mg/dL).
• Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST \> 3x upper limit of normal (ULN), or serum total bilirubin (TB) \>34.2 μmol/L (\>2 mg/dL).
• Patiens with following renal disease history or renal disease related features:
• History of unstable or rapidly progressing renal disease;
• Patients with moderate /severe renal impairment or end-stage renal disease (eGFR\< 60 mL/min/1.73 m2)
• Urinary albumin: creatinine ratio \>1800 mg/g;
• Serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL) for male subjects; Serum Cr≥124 μmol/L (≥1.40 mg/dL) for female subjects;
• Conditions of congenital renal glycosuria.
• Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or BP ≥110 mmHg;Patients with SBP \< 95mmHg.
• Any of the following cardiovascular diseases within 6 months of the enrollment visit:

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Research Site

Beijing, 100034, China

Location

Research Site

Changsha, 410013, China

Location

Research Site

Changsha, 430033, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Guangzhou, 510080, China

Location

Research Site

Guangzhou, 510630, China

Location

Research Site

Hangzhou, 310014, China

Location

Research Site

Hangzhou, 310020, China

Location

Research Site

Hefei, 230022, China

Location

Research Site

Shanghai, 200032, China

Location

Research Site

Shenyang, 110001, China

Location

Research Site

Shijiazhuang, 050001, China

Location

Research Site

Ürümqi, 830054, China

Location

Research Site

Xi'an, 710061, China

Location

Research Site

Zhengzhou, China

Location

Related Publications (1)

• 1. Montironi R, Schulman CC. Pathological changes in prostate lesions after androgen manipulation. J Clin Pathol 1998; 51:5-12. 2. Witjes WP, Schulman CC, Debruyne FM. Preliminary results of a prospective randomized study comparing radical prostatectomy versus radical prostatectomy associated with neoadjuvant hormonal combination therapy in T2-3 N0 M0 prostatic carcinoma. Urology 1997;49(suppl):65-9. 3. Labrie F, Cusan L, Gomez JL, et al. Neoadjuvant hormonal therapy: the Canadian experience. Urology 1997;49(suppl):56-60. 4. Soloway MS, Sharifi F, Wajsman Z, et al. Random prospective study comparing radical prostatectomy alone versus radical prostatectomy preceded by androgen blockade in clinical stage B2 (T2bNxM0) prostate cancer. J Urol 1995; 154:424-8. 5. Hugosson J, Abrahamsson PA, Ahlgren G, et al. The risk of malignancy in the surgical margin at radical prostatectomy is reduced almost three-fold in patients given neoadjuvant hormone treatment. Eur Urol 1996; 29:413-16.

  RESULT

MeSH Terms

Interventions

Goserelin; bicalutamide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Xin Gao

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: June 3, 2019
• Study Start: January 28, 2021
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)