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Castration-resistant Prostate CancerPhase 1/2NCT04148885

A Trial of Paclitaxel (Albumin-binding) for Castration-resistant Prostate Cancer

A Phase 1/2 study testing nab-paclitaxel and carboplatin in people with Castration-resistant Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

One-arm, multi-center clinical trial of paclitaxel (albumin-binding) combined with carboplatin for castration-resistant prostate cancer Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Castration-resistant Prostate Cancer
What is being tested?
nab-paclitaxel and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
No sites listed yet
Study dates
Nov 2019to Dec 2020
Phase
Phase 1/2
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

  • Age ≥18 years, Male;
  • diagnosed as prostate cancer by histopathology or cytology;
  • Confirmed as castration-resistant prostate cancer: 1 interval 1 week, 3 consecutive PSA minimum values increased by >50%; 2 serum testosterones <50ng/dl or <1.7nmol/L [Guide of the Chinese Urological Association (2015) The diagnostic criteria of CRPC];
  • There are no other concurrent anti-cancer treatments (including local radiotherapy, systemic chemotherapy, and molecular targeted therapy) or previous treatment history;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • The estimated survival period is more than 3 months;
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  • having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria;
  • No obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment;
  • Liver function test: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value, if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance rate ≥50ml/min;
  • Understand the circumstances of this study, patients and/or legal representatives voluntarily agree to participate in the trial and sign informed consent.

Who cannot join

  • • Have a birth plan during the clinical trial;
  • Patients with brain metastases;
  • Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;
  • Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;
  • Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;
  • Allergy or hypersensitivity history of the drug or drug ingredient used in this test;
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  • Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;
  • Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
  • The investigator believes that it is not suitable for inclusion.

Trial locations and contacts

No sites are listed yet.

Li Qi, MD PHD contact

+8618121288167

Leeqi2001@hotmail.com

About this study

Official title: One-arm, Multi-center Clinical Trial of Paclitaxel (Albumin-binding) Combined With Carboplatin for Castration-resistant Prostate Cancer

One-arm, multi-center clinical trial of paclitaxel (albumin-binding) combined with carboplatin for castration-resistant prostate cancer

Read the detailed description

Prostate cancer is one of the most common malignant tumors of the male genitourinary system. In 2017, the American Oncology Society will report that 161,360 new prostate cancers were estimated, accounting for 21% of male tumors, ranking first in male new tumors; 26,730 death, cancer death. The rate is second only to bronchial lung cancer and colorectal cancer. In China, although the incidence of prostate cancer is lower than the world epidemiological level, the incidence of prostate cancer in China has shown an increasing trend in recent years. The latest statistics from the National Cancer Center 2017, the incidence of male prostate cancer is 2.4%, which is a male malignant tumor. Seventh place in the disease. The taxane drug docetaxel showed good anti-tumor activity in castration resistant prostate cancer (CRPC) patients, and paclitaxel combined with carboplatin also had a certain effect on CRPC. However, in clinical practice, patients with prostate cancer are mostly old, often accompanied by other underlying diseases, poor physical status, and poor tolerance in the use of docetaxel and paclitaxel. Albumin-bound paclitaxel has more tumor-targeted enrichment than traditional paclitaxel and is less toxic. Therefore, this study intends to explore the efficacy and safety of albumin-bound paclitaxel combined with carboplatin in the treatment of CRPC, providing a reference for the treatment options of CRPC in clinical practice.

Keywords
castration-resistant prostate cancer, paclitaxel (albumin-binding), carboplatin

What participants receive

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

  • nab-paclitaxelDrug

    Also called Abraxane

    Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

  • carboplatinDrug

    Also called Paraplatin, Carboplat, Ercar

    Patients secondly receive carboplatin AUC=5 (iv, 30 minutes) on days 1 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Study groups in NCT04148885
Study groupRoleWhat they receive
nab-paclitaxel + CarboplatinExperimentalnab-paclitaxel at 260 mg/m^2 on days 1; Carboplatin AUG=5, d1, 21 days in one cycle, 3 cycles in total
Receives: Drug: nab-paclitaxel; Drug: carboplatin

What is being measured

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

  1. Prostate specific antigen (PSA)

    PSA was effective: PSA decreased by ≥ 50% for more than 4 weeks, and there was no evidence of clinical and imaging progression; PSA progression: PSA increased more than 25% of baseline or baseline during chemotherapy, and the absolute value was ≥ 5 ng/ml.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary outcomes (3)

  1. ORR

    Objective Response Rate

    Measured: From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter

  2. TTF

    Time to treatment failure

    Measured: From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter

  3. OS

    Overall survival

    Measured: From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter

Timeline

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

  1. First posted4 Nov 2019
  2. Study startNov 2019 (estimated)
  3. Primary completionJul 2020 (estimated)
  4. Study completionDec 2020 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148885
Sponsor's protocol ID
CSPC-KAL-PC-01
Status last verified
Oct 2019
First submitted
29 Oct 2019
Last updated
4 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nab-paclitaxel and carboplatin in people with Castration-resistant Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.

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 10 inclusion and 9 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Li Qi, MD PHD (+8618121288167, Leeqi2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate specific antigen (PSA) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 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 NCT04148885.

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 4 Nov 2019.

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