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Advanced Prostate CancerPhase 4NCT03971110

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

A Phase 4 study testing Zoladex and Casodex in people with Advanced Prostate Cancer, run by AstraZeneca at 15 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Advanced Prostate Cancer
What is being tested?
Zoladex and Casodex
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
15 sitesChina
Study dates
28 Jan 2021to 9 Nov 2022
Phase
Phase 4
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 34Show fewer
  • 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:
  • Myocardial infarction;
  • Cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty);
  • Unstable angina;
  • Congestive heart failure New York Heart Association Class III or IV;
  • Transient ischemic attack or significant cerebrovascular disease.
  • History of gastrointestinal disease or surgery including Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer, gastroenterostomy, enterectomy, bariatric surgery or lap-band procedure.
  • Malignancy within 5 years of the enrollment visit (with the exception of treated basal cell or treated squamous cell carcinoma).
  • Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
  • Any subject who, in the judgment of the investigator, was at risk for dehydration or volume depletion that might affect the interpretation of efficacy or safety data.
  • History of bone fracture secondary to diagnosed severe osteoporosis.
  • Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases as judged by the Investigator.
  • Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for >4 weeks within 3 months before enrollment visit.
  • Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, or phendimetrazine within 30 days of enrollment visit.
  • Any subject who was currently abusing alcohol or other drugs or had done so within the last 6 months
  • Donation of blood or blood products, blood transfusion, or participation in a clinical study requiring withdrawal of >400 mL of blood during the 6 weeks before the enrollment visit
  • History of hypersensitivity reaction to dapagliflozin or acarbose. Allergies or contraindication to the contents of dapagliflozin tablets or acarbose tablests.
  • Previous participation in a clinical trial with dapagliflozin.
  • Administration of any other investigational drug within 30 days of planned enrollment to this study, or within 5 half-life periods of other investigational drugs.
  • Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Research Site

    Beijing, 100034

  • Research Site

    Changsha, 410013

  • Research Site

    Changsha, 430033

  • Research Site

    Chengdu, 610041

  • Research Site

    Guangzhou, 510080

  • Research Site

    Guangzhou, 510630

  • Research Site

    Hangzhou, 310014

  • Research Site

    Hangzhou, 310020

  • Research Site

    Hefei, 230022

  • Research Site

    Shanghai, 200032

  • Research Site

    Shenyang, 110001

  • Research Site

    Shijiazhuang, 050001

  • Research Site

    Ürümqi, 830054

  • Research Site

    Xi'an, 710061

  • Research Site

    Zhengzhou

Other trials in China

About this study

Official title: A Multi-centre, Single-arm, Prospective 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.

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.

Read the detailed description

Neoadjuvant hormonal treatment (NHT) for clinically localised prostate cancer consists of complete androgen blockade (CAB) preceding either radiotherapy or surgery. The rational for this approach is based on the assumption that NHT will reduce both the tumour and normal prostatic tissue volume, and induce cancer regression by the mechanism of apoptosis [1].

Most randomized clinical trials show that NHT reduces the incidence of positive surgical margins after radical prostatectomy and apparently determines tumour downstaging, however no advantage has been documented in terms of biochemical disease progression [for example, time to prostate specific antigen (PSA) increase] between treated and untreated patients [2-8]. Because of relatively low biological aggressiveness of prostatic carcinoma, many patients will need to be followed for a considerable time before drawing significant conclusions on the effects of NHT on survival [2,4,7,10]. A large sample of 393 radical prostatectomy specimens were evaluated in 3 treatment groups, which were immediate surgery, 12 weeks of NHT (Zoladex and Casodex), and 24 weeks of NHT. Patients included clinical stage B (T2a and T2b) and stage C (T3a and T3b). Systemic hormonal treatment, whether 12 weeks or 24 weeks of NHT, is able to "downstage" the primary tumour and decrease the positive margin rate before definitive localised treatment [11].

Currently treatment of patients with oligometastatic prostate cancer is undergoing dramatic changes [12]. The local treatment of the primary tumour might provide a survival benefit to men with metastatic and lymph node-positive disease. Similar observations have been made in treatment of metastatic lesions with life-prolonging, rather than palliative intent [13-17].

This study is proposed primarily to observe the efficacy and safety of 24-week NHT (Zoladex and Casodex) in patients with locally advanced or oligometastatic prostate cancer. Progression status and survival will be followed-up for up to 2 years after NHT.

This is a multi-centre, single-arm and prospective study to explore the efficacy and safety of neoadjuvant hormone therapy (NHT) for advanced prostate cancer patients undergoing radical prostatectomy (RP). A total of 104 subjects with locally advanced and oligometastatic prostate cancer at clinical stage of T3 and T4 will be enrolled at almost 20 centres in China.

The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously every 12 weeks as neoadjuvant therapy for 24 weeks, and then will be assessed for resectability of the primary tumour. The subjects will undergo a RP [RALP (robot-assisted laparoscopic prostatectomy), laparoscopic RP or RRP (radical retropubic prostatectomy)] plus eLND thereafter if the primary tumour is assessed as resectable. Surgical margin status and involvement of bilateral pelvic lymph nodes will be evaluated. Subjects will be prescribed post-surgical treatment such as continuous ADT and metastasis-directed therapy upon investigator's discretion and be followed-up for up to 2 years.

Progression free survival (PFS) and overall survival (OS) will be collected during this study.

For the subjects with unresectable primary tumour after NHT, PFS and OS will also be collected in the follow-up for up to 2 years after 24 weeks of CAB.

Being tested
Zoladex and Casodex

What participants receive

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

  • Zoladex and CasodexDrug

    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.

Study groups in NCT03971110
Study groupRoleWhat they receive
Zoladex and CasodexExperimentalSubjects 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.
Receives: Drug: Zoladex and Casodex

What is being measured

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

  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

    Measured: at 24 week

Secondary outcomes (11)

  1. Radical prostatectomy rate

    Which will be derived using the number of patient who will conduct the radical prostatectomy at 24 week.

    Measured: From baseline to 24 week

  2. The mean PSA by the end of NHT

    which will be derived using the value of mean PSA by the end of NHT

    Measured: From baseline to 24 week

  3. Percentage of positive surgical margin for primary tumour

    Which will be derived using the number of positive surgical margin at 24 week

    Measured: From baseline to 24 week

  4. Incidence of seminal vesicle invasion

    Which will be derived using the value of incidence of seminal vesicle invasion at 24 week

    Measured: From baseline to 24 week.

  5. Percentage of pathological downstaging

    Which will be derived using the number of pathological downstaging at 24 week.

    Measured: From baseline to 24 week

  6. surgical-related variables at 12 weeks, potent rates in erectile function at 12 weeks after surgery

    Which will be derived using the value of observe surgical-related variables and complications at week 36

    Measured: From 24 week to 36 week

  7. PFS

    Which will be derived using the number of PFS at the end of study

    Measured: From baseline to the end of study

  8. AEs/SAEs

    To evaluate the safety of NHT using goserelin and bicalutamide

    Measured: From baseline to 28 week

  9. PSA change from baseline

    Which will be derived using the value of PSA at the baseline.

    Measured: From baseline to 24 week

  10. Involvement of bilateral pelvic lymph nodes

    Which will be derived using the value of involvement of bilateral pelvic lymph nodes at 24 week.

    Measured: From baseline to 24 week

  11. OS

    Which will be derived using the number of OS at the end of study.

    Measured: From baseline to the end of study

Timeline

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

  1. First posted3 Jun 2019
  2. Study start28 Jan 2021
  3. Primary completion9 Nov 2022
  4. Study completion9 Nov 2022

Why it stopped: Due to the limited potential patients pool, the enrollment goal could not be achieved. After review and communication, the decision to teminate study was made.

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03971110
Sponsor's protocol ID
D8664C09827
Status last verified
Dec 2022
First submitted
21 Mar 2019
Last updated
16 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zoladex and Casodex in people with Advanced Prostate Cancer, run by AstraZeneca at 15 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 8 inclusion and 34 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: stopped early, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early (reason given: Due to the limited potential patients pool, the enrollment goal could not be achieved. After review and communication, the decision to teminate study was made.). Results are not available in the source record.

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?

Resectability rate for primary tumour (the resectability will be assessed by central review using a digital rectal examination and confirmed by CT or MRI) (time frame: at 24 week). 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 NCT03971110, 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 Dec 2022.

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