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Hormone-Resistant Prostate CancerPhase 2NCT02985021

Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies

A Phase 2 study testing Carboplatin and Docetaxel in people with Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by Seattle Institute for Biomedical and Clinical Research at 3 sites in United States.

Terminated

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

Official record
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Trial summary

In this study, patients who have metastatic prostate cancer that does not respond to hormone treatment and who have mutations in certain cancer-related genes will be treated with docetaxel and carboplatin chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Carboplatin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesUnited States
Study dates
Nov 2016to Apr 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients meeting the following inclusion criteria will be eligible to participate in this study:
  • Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information.
  • Age > 18 years
  • Known prostate cancer
  • Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy.
  • Castration resistant prostate cancer as defined by serum testosterone < 50ng/ml and one of the following:
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  • PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart.
  • Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors).
  • Progression of metastatic bone disease on bone scan with > 2 new lesions.
  • Prior therapy with abiraterone acetate, enzalutamide, or docetaxel. There is no limit to the number of prior treatment regimens.
  • Presence of metastatic disease on scans.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Life expectancy >12 weeks.
  • No prior malignancy is allowed except:
  • Adequately treated basal cell or squamous cell skin cancer or
  • In situ carcinoma of any site or
  • Other adequately treated malignancy for which the patient has been disease-free for at least one year (any prior chemotherapy is allowed).
  • Patients must have adequate organ and marrow function as defined below obtained within 14 days prior to start of therapy:
  • Absolute neutrophil count >1.5 x 109 cells/L
  • Hgb > 9.0 g/dL
  • Platelets >100,000 x 109/L
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin levels < 1.5 x Upper Limit of Normal (ULN)
  • Presence of germline inactivation of BRCA1, BRCA2, ATM OR one of the following:
  • Patients with clearly deleterious germline mutations of other genes involved in homologous DNA repair may be included at the investigator's discretion.
  • Patients with homozygous inactivation of genes involved in homologous recombination from primary or metastatic tumor as assessed by a Clinical Laboratory Improvement Amendments (CLIA) level assay for DNA sequencing may be included.
  • Patients with a signature of homologous recombination deficiency in primary or metastatic tissue may be included (VA Puget Sound only).

Who cannot join

  • Patients who meet any of the following criteria will be excluded from the study:
  • Currently receiving active therapy for other neoplastic disorders.
  • Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendocrine differentiation without morphologic evidence is not exclusionary).
  • Prior treatment with platinum-based chemotherapy for prostate cancer.
  • Known parenchymal brain metastasis.
  • Active or symptomatic viral hepatitis or chronic liver disease.
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  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 35 % at baseline, if done.
  • Treatment with an investigational therapeutic within 30 days of Cycle 1.
  • Patients with dementia/psychiatric illness/social situations limiting compliance with study requirements or understanding and/or giving of informed consent are not eligible
  • Any medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained are not eligible.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • VA Ann Arbor Health Care System

    Ann Arbor, Michigan, 48105

  • VA Greater Los Angeles - West LA

    Los Angeles, California, 90073

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

Other trials in United States

About this study

Official title: A Phase 2 Study of Docetaxel and Carboplatin for Treatment of Patients With Metastatic, Castration Resistant Prostate Cancer and Germline or Somatic DNA Repair Deficiency

In this study, patients who have metastatic prostate cancer that does not respond to hormone treatment and who have mutations in certain cancer-related genes will be treated with docetaxel and carboplatin chemotherapy.

Read the detailed description

This is a phase 2 study of the combination of docetaxel and carboplatin in patients with germline inactivation of genes in the homologous recombination pathway, including BRCA1, BRCA2, and Ataxia Telangiectasia Mutated (ATM).

PRIMARY OBJECTIVE To assess rate of 50% Prostate Specific Androgen (PSA) decline to docetaxel and carboplatin

Being tested
Carboplatin, Docetaxel
Medical subject headings
Prostatic Neoplasms

What participants receive

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

Study groups in NCT02985021
Study groupRoleWhat they receive
Treatment (docetaxel, carboplatin)ExperimentalDocetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle. Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Docetaxel

What is being measured

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

  1. Percentage of Patients Achieving >= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria

    Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy

    Measured: From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)

Timeline

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

  1. First posted7 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionApr 2021
  4. Study completionApr 2021

Why it stopped: Competing studies

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985021
Sponsor's protocol ID
PugetSoundVA
Status last verified
Aug 2021
First submitted
22 Nov 2016
Last updated
5 Aug 2021
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin and Docetaxel in people with Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by Seattle Institute for Biomedical and Clinical Research at 3 sites in United States.

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 26 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: stopped early, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Achieving >= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria (time frame: From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)). 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 NCT02985021.

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 5 Aug 2021.

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