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Prostate CancerPhase 2NCT04736108

Neoadjuvant Therapy of Abiraterone Plus ADT for Intraductal Carcinoma of the Prostate

A Phase 2 study testing Abiraterone acetate, Prednisolone and Goserelin in people with Prostate Cancer, run by West China Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Neoadjuvant treatment before radical prostatectomy has been proven to provide benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abiraterone acetate, Prednisolone and Goserelin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
May 2021to Dec 2024
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Histologically or cytologically diagnosis of prostate cancer with positive IDC-P status
  • High-risk localized prostate cancer, defined by either: Tumor stage ≥T3a by digital rectal examination, or Primary tumor Gleason score ≥ 8, or PSA > 20 ng/mL
  • No evidence of metastases
  • The ECOG score of the patient is ≤2
  • Expected survival over 5 years
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  • 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
  • Agree to collect the tumor tissue and blood samples needed for the research and apply them to related study
  • Adequate hematologic, renal and hepatic function:
  • Absolute neutrophil count [ANC] ≥1.5 x 10^9/L
  • Platelet count [PLT] ≥100 x 10^9/L
  • Hemoglobin [HGB] ≥9 g/dL
  • Serum Total bilirubin [TBIL] ≤1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 2.5 x ULN
  • Serum albumin [ALB] ≥2.8 g/dL
  • Serum Creatinine ≤ 1.5 x ULN
  • Creatinine Clearance ≥ 40 mL/min

Who cannot join

  • Prior androgen deprivation therapy (medical or surgical), radiation therapy or chemotherapy for prostate cancer
  • Evidence of metastatic disease (M1) on imaging studies
  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
  • Major surgery or severe trauma within 30 days before enrollment
  • Patients with severe or uncontrolled concurrent，including but not limited to：
  • Severe or uncontrolled concurrent infections
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  • Human immunodeficiency virus [HIV] infection positive
  • Suffer from acute or chronic active hepatitis B (HBsAg positive and HBV DNA>1x10^3/mL) Or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA>15 IU/mL)
  • Active tuberculosis, etc
  • Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure，or clinically significant ventricular arrhythmias
  • Uncontrolled hypertension（Systolic blood pressure≥160mmHg or Diastolic blood pressure≥100mmHg）
  • Severe or unstable angina, myocardial infarction，arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks) Occurred within 6 months before enrollment
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
  • Any condition that in the opinion of the investigator, would preclude participation in this study

Trial locations and contacts

1 site in 1 country.

Hao Zeng, Professor contact

008618980602129

kucaizeng@163.com

China1 site

  • West China Hospital

    Chengdu, Sichuan, 610000

    Hao Zeng, Professor, 008618980602129, kucaizeng@163.com

Other trials in China

About this study

Official title: A Single-center, Phase II Neoadjuvant Study of Abiraterone Acetate in the Treatment of Intraductal Carcinoma of the Prostate

Neoadjuvant treatment before radical prostatectomy has been proven to provide 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 abiraterone acetate Plus androgen deprivation therapy（ADT）in high-risk localized prostate cancer with intraductal carcinoma of the prostate（IDC-P）.

Read the detailed description

IDC-P is an adverse pathological entity of prostate cancer, characterized by the growth of malignant cells in pre-existing prostatic ducts and acini, and is present in high-grade disease and associated with poor prognosis. Previous studies have shown that IDC-P was significantly associated with an adverse clinical course in patients who received radical prostatectomy or radiotherapy, and the presence of IDC-P on the biopsy specimen was associated with a poor prognosis in terms of overall survival (OS) and a poor docetaxel response in patients with distant metastasis at the initial diagnosis. Our previous researches as well as other published data indicated that abiraterone had a better therapeutic efficacy than docetaxel as the first-line therapy in metastatic castration resistance prostate cancer（mCRPC）with IDC-P. Therefore we intended to perform this single-arm phase II clinical trial to evaluate the initial efficacy and safety of abiraterone acetate Plus ADT as neoadjuvant therapy for high-risk localized prostate cancer with IDC-P. The primary endpoint is the pathologic complete response (pCR).

Conditions
Prostate Cancer
Being tested
Abiraterone acetate, Prednisolone, Goserelin
Keywords
abiraterone acetate
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 radical prostatectomy

  • PrednisoloneDrug

    5 mg oral low dose prednisone, once daily

  • GoserelinDrug

    10.8 mg goserelin hypodermic once per 12 weeks

Study groups in NCT04736108
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 radical prostatectomy
Receives: Drug: Abiraterone acetate; Drug: Prednisolone; Drug: Goserelin

What is being measured

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

  1. Pathologic Complete Response Rate（pCR）

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

    Measured: 6 months

Secondary outcomes (11)

  1. Rate 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: 6 months

  2. Rate of positive surgical margin (PSM)

    The rate of positive surgical margins in the prostatectomy specimen after neoadjuvant therapy.

    Measured: 6 months

  3. Rate of Nodal Metastases After 6 Months of Treatment

    The rate of the presence of tumor cells within surgically excised lymph nodes will be assessed after 6 months of neoadjuvant treatment.

    Measured: 6 months

  4. Rate of Pathologic T3 Disease After 6 Months of Treatment

    The rate of the presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 6 months of neoadjuvant treatment.

    Measured: 6 months

  5. Biochemical Progression-free Survival (bPFS)

    Biochemical progression will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy >= 0.2 ng/mL) or death. Will be estimated using Kaplan-Meier methods and 95% CI will be estimated using Greenwood's formula.

    Measured: 2 years

  6. PSA decline rate

    The rate of PSA decline to baseline PSA after 6 months of neoadjuvant therapy.

    Measured: 6 months

  7. Incidence and severity of adverse events

    Safety as assessed by the incidence and severity of adverse events and serious adverse events graded according to the National Cancer Institute - Common Terminology Criteria for adverse events (CTCAE) version 4.0.

    Measured: 6 months

  8. Quality of life (QOL) as assessed by FACT-P

    The QOL will be measured using the functional assessment of cancer therapy-prostate（FACT-P）. The questionnaires will be administered at baseline, prior to RP and every 3 months for 2 years post RP.

    Measured: Up to 24 months after surgery

  9. Quality of life as assessed by EQ-5D

    The QOL will be measured using the EuroQol five dimensions questionnaire（EQ-5D）. The questionnaires will be administered at baseline, prior to RP and every 3 months for 2 years post RP.

    Measured: Up to 24 months after surgery

  10. Radiographic progression-free survival (rPFS)

    Time from surgery to radiographic progression or death

    Measured: 2 years

  11. Overall survival

    Time from surgery to death due to any cause

    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 posted3 Feb 2021
  2. Study startMay 2021 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionDec 2024 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736108
Sponsor's protocol ID
20201224
Other IDs
Dragon-001
Status last verified
Feb 2021
First submitted
29 Jan 2021
Last updated
8 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Humphrey PA, Moch H, Cubilla AL, Ulbright TM, Reuter VE. The 2016 WHO Classification of Tumours of the Urinary System and Male Genital Organs-Part B: Prostate and Bladder Tumours. Eur Urol. 2016 Jul;70(1):106-119. doi: 10.1016/j.eururo.2016.02.028. Epub 2016 Mar 17.

    PubMed 26996659

  • Efstathiou E, Abrahams NA, Tibbs RF, Wang X, Pettaway CA, Pisters LL, Mathew PF, Do KA, Logothetis CJ, Troncoso P. Morphologic characterization of preoperatively treated prostate cancer: toward a post-therapy histologic classification. Eur Urol. 2010 Jun;57(6):1030-8. doi: 10.1016/j.eururo.2009.10.020. Epub 2009 Oct 17.

    PubMed 19853370

  • Van der Kwast T, Al Daoud N, Collette L, Sykes J, Thoms J, Milosevic M, Bristow RG, Van Tienhoven G, Warde P, Mirimanoff RO, Bolla M. Biopsy diagnosis of intraductal carcinoma is prognostic in intermediate and high risk prostate cancer patients treated by radiotherapy. Eur J Cancer. 2012 Jun;48(9):1318-25. doi: 10.1016/j.ejca.2012.02.003. Epub 2012 Mar 8.

    PubMed 22405699

  • Kumar S, Shelley M, Harrison C, Coles B, Wilt TJ, Mason MD. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006019. doi: 10.1002/14651858.CD006019.pub2.

    PubMed 17054269

  • Zhao T, Liao B, Yao J, Liu J, Huang R, Shen P, Peng Z, Gui H, Chen X, Zhang P, Zhu Y, Li X, Wei Q, Zhou Q, Zeng H, Chen N. Is there any prognostic impact of intraductal carcinoma of prostate in initial diagnosed aggressively metastatic prostate cancer? Prostate. 2015 Feb 15;75(3):225-32. doi: 10.1002/pros.22906. Epub 2014 Oct 13.

    PubMed 25307858

  • Chen Z, Chen N, Shen P, Gong J, Li X, Zhao T, Liao B, Liu L, Liu Z, Zhang X, Liu J, Peng Z, Chen X, Xu M, Gui H, Zhang P, Wei Q, Zhou Q, Zeng H. The presence and clinical implication of intraductal carcinoma of prostate in metastatic castration resistant prostate cancer. Prostate. 2015 Sep;75(12):1247-54. doi: 10.1002/pros.23005. Epub 2015 Apr 27.

    PubMed 25917338

  • Zhao J, Shen P, Sun G, Chen N, Liu J, Tang X, Huang R, Cai D, Gong J, Zhang X, Chen Z, Li X, Wei Q, Zhang P, Liu Z, Liu J, Zeng H. The prognostic implication of intraductal carcinoma of the prostate in metastatic castration-resistant prostate cancer and its potential predictive value in those treated with docetaxel or abiraterone as first-line therapy. Oncotarget. 2017 Jul 24;8(33):55374-55383. doi: 10.18632/oncotarget.19520. eCollection 2017 Aug 15.

    PubMed 28903426

  • Porter LH, Lawrence MG, Ilic D, Clouston D, Bolton DM, Frydenberg M, Murphy DG, Pezaro C, Risbridger GP, Taylor RA. Systematic Review Links the Prevalence of Intraductal Carcinoma of the Prostate to Prostate Cancer Risk Categories. Eur Urol. 2017 Oct;72(4):492-495. doi: 10.1016/j.eururo.2017.03.013. Epub 2017 Mar 22.

    PubMed 28342640

  • de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

    PubMed 21612468

  • James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, Sydes MR; STAMPEDE Investigators. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.

    PubMed 28578639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate, Prednisolone and Goserelin in people with Prostate Cancer, run by West China Hospital 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 17 inclusion and 14 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 8 Feb 2021. 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?

Contact Hao Zeng, Professor (008618980602129, kucaizeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response Rate（pCR） (time frame: 6 months). 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 NCT04736108, which also lists 11 linked publications.

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 8 Feb 2021.

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