AzTrials
AzTrials

Prostate CancerPhase 2NCT04356430

Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer

A Phase 2 study testing Abiraterone Acetate, Prednisone and Goserelin 10.8 mg in people with Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abiraterone Acetate, Prednisone and Goserelin 10.8 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChina
Study dates
1 Apr 2019to 1 Dec 2023
Phase
Phase 2
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 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be ≥ 18 and ≤75 years of age.
  • All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
  • All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml.
  • Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1
  • Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 / L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9 g / dL, and international normalized ratio (INR) < 1.5.
  • Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN.
  • Patients must have adequate renal function, within 28 days prior to registration, as evidenced by serum creatinine ≤2×ULN
  • Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.

Who cannot join

  • Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
  • Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3, Gleason score of primary tumor < 8, and prostate specific antigen (PSA) <20 ng/ml.
  • Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.
  • Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.
  • Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy are not eligible.
  • Patients with severe or uncontrolled concurrent infections are not eligible.
Show all 10Show fewer
  • Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
  • Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
  • Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
  • Patients with mental illness, mental disability or inability to give informed consent are not eligible.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Neoadjuvant treatment before radical prostatectomy had been proven to get some benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa.

Conditions
Prostate Cancer
Being tested
Abiraterone Acetate, Prednisone, Goserelin 10.8 mg
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Abiraterone AcetateDrug

    1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy

  • PrednisoneDrug

    5 mg oral low dose prednisone, once daily

  • Goserelin 10.8 mgDrug

    10.8 mg goserelin hypodermic once per 12 weeks

Study groups in NCT04356430
Study groupRoleWhat they receive
ADT with Abiraterone and prednisoneExperimentalAll subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus abiraterone acetate and prednisone, as per standard of care. Goserelin 10.8 mg will be used once per 12 weeks. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone once per day. Subjects will continue to take abiraterone acetate and prednisone for 24 weeks before robotic assisted radical prostatectomy
Receives: Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Goserelin 10.8 mg
ADT aloneExperimentalAll subjects in this arm will receive LHRHa alone for 24 weeks before receiving robotic assisted radical prostatectomy. Goserelin 10.8 mg will be administered once per 12 weeks.
Receives: Drug: Goserelin 10.8 mg

What is being measured

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

  1. Pathologic Complete Response Rate

    The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy

    Measured: up to 8 months

  2. Proportion of Subjects With Minimal Residual Disease

    The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy

    Measured: up to 8 months

Secondary outcomes (8)

  1. Rate of Stage Degradation

    Clinical or pathological stage degradation after neoadjuvant therapy

    Measured: up to 8 months

  2. Rate of Positive Surgical Margins

    The proportion of subjects with positive surgical margins after radical prostatectomy

    Measured: up to 8 months

  3. Rate of Complete Serum Remission

    The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment

    Measured: up to 6 months

  4. Proportion of subjects without PSA progression

    The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy

    Measured: 24 months

  5. Imaging Response Rate

    The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm

    Measured: up to 8 months

  6. Recovery time of urinary continence (day)

    The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.

    Measured: 12 month

  7. biochemical recurrence-free survival (bRFS)

    biochemical recurrence-free survival (bRFS) defined as time to PSA ≥ 0.2 ng/ml after radical prostatectomy.

    Measured: 3 years

  8. metastasis-free survival (MFS)

    time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.

    Measured: 5 years

Timeline

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

  1. First posted22 Apr 2020
  2. Study start1 Apr 2019
  3. Primary completion1 Mar 2021
  4. Study completion1 Dec 2023 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356430
Sponsor's protocol ID
IUNU-PC-101
Status last verified
Dec 2021
First submitted
12 Apr 2020
Last updated
16 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhuang J, Wang Y, Zhang S, Fu Y, Huang H, Lyu X, Zhang S, Marra G, Xu L, Qiu X, Guo H. Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials. Front Pharmacol. 2023 Jun 26;14:1217303. doi: 10.3389/fphar.2023.1217303. eCollection 2023.

    PubMed 37435500

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Prednisone and Goserelin 10.8 mg in people with Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site 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 10 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: status not confirmed, 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Pathologic Complete Response Rate (time frame: up to 8 months). 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 NCT04356430, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in