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Castrate Resistant Prostate CancerPhase 1NCT01144897

PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy

A Phase 1 study testing PET Acetate scan and Carbon-11 labeled Acetate in people with Castrate Resistant Prostate Cancer and Prostate Cancer, run by Daniel Vaena at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One purpose of this research study is to examine if a special type of imaging test, a positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate cancer (CRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
PET Acetate scan and Carbon-11 labeled Acetate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
May 2010to Sep 2018
Phase
Phase 1
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

  • Ability to understand and willingness to sign a written consent document.
  • Patients must have histologically documented adenocarcinoma of the prostate at any time in the past.
  • At the time of enrollment: Patients must have evidence of castrate resistant metastatic prostate cancer (patients with rising PSA only and no other radiographic evidence of metastatic prostate cancer are not eligible). In addition, progressive disease is required as per #5 below.
  • Two categories of eligible patients exist: Measurable disease with any level of serum prostate-specific antigen (PSA) OR Non-measurable disease (positive bone scan) with PSA equal or greater than 2 ng/ml
  • Definition of Measurable Disease/Target Lesions - Any lesion >/= 1 cm on spiral computed tomography (CT) that is believed to represent metastatic prostate cancer and that can be accurately measured in at least one dimension (longest diameter). However, if the lesion is a lymph node, it needs to be equal or greater than 20 mm (longest diameter) based on CT scans or physical exam (palpable lymph nodes). Chest X-ray with clearly defined lung lesions surrounded by aerated lung or parenchymal lung lesions measured as 10 mm or greater with a spiral CT are also eligible.
  • Definition of Non-measurable Disease/Non-target Lesions - Non-target lesions include all other lesions not included above, including bone lesions. Previously irradiated lesions should not be used for eligibility unless progression was documented after radiation therapy.
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  • In order to be eligible, patients must have demonstrated evidence of progressive disease prior to enrollment. Progressive disease is defined as any one of the following:
  • Measurable Disease Progression: Objective evidence of increase 20% or more in the sum of the longest diameters (LD) of target lesions from the time of maximal regression after prior therapy; or the appearance of one or more new lesions.
  • Bone Scan Progression: Appearance of two or more new lesions on bone scan. If no prior bone scan exists, presence of 2 lesions is needed for eligibility.
  • PSA Progression: An elevated PSA (2 ng/mL or higher) which has risen serially on at least two occasions at least each 1 week apart. Note: If patient was on antiandrogens as last therapy, 6 weeks need to elapse after discontinuation of the antiandrogen. For prior ketoconazole, 4 weeks need to elapse. If the confirmatory PSA (#2) value is less than the first rising PSA value, then an additional rising PSA (#3) will be required to document progression. For the purposes of this study, the last PSA value recorded prior to the initiation of treatment will be considered the baseline PSA.
  • Progression despite standard androgen deprivation therapy.
  • At least 4 weeks since any systemic steroids (any dose; unless used chronically for another illness at equal or less than 10 mg of prednisone daily, or in conjunction with prior ketoconazole resulting in slow steroid taper) and any other hormonal therapy.
  • No prior cytotoxic chemotherapy for prostate cancer.
  • Four weeks or longer since major surgery and fully recovered.
  • Four weeks or longer since any prior radiation (including palliative) and fully recovered.
  • No prior strontium or samarium.
  • Concurrent bisphosphonate use is allowed. However, if patient has not previously been on bisphosphonate, first dose should only occur after the baseline positron emission tomography (PET) acetate scan has been obtained.
  • ECOG performance status: 0-2
  • Age ≥ 18
  • Required Initial Laboratory Values (within 14 days of registration):
  • ANC ≥1500/microL; Platelet count ≥ 100,000/microL; Creatinine ≤1.5 x upper limits of normal; Bilirubin ≤ 1.5 x upper limits of normal; AST and ALT ≤ 1.5 x upper limits of normal; PSA level requirements: see #4; Serum Testosterone ≤ 50 ng/ dL (for patients who have not had bilateral orchiectomy); Estimated glomerular filtration rate > 30 mL/min

Who cannot join

  • No known brain metastases (brain imaging MRI/CT is not required unless clinical symptoms).
  • No current congestive heart failure (New York Heart Association Class III or IV).
  • No serious or non-healing wound, ulcer or bone fracture.
  • No peripheral neuropathy ≥ grade 2.
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible.
  • Patients who received prior docetaxel for any reason are not eligible.
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  • PC-Spes, Saw Palmetto, and St. John's Wort must be discontinued before registration. The discontinuation of other herbal medications and food supplements is strongly encouraged. Patients may continue on daily vitamins and calcium supplements.
  • No known allergy to acetate.
  • No severe claustrophobia
  • Concurrent use of statins is allowed on study but use should not have started 30 days prior to entry into the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: PET Acetate for Docetaxel Response Assessment in Hormone-Refractory Prostate Cancer

One purpose of this research study is to examine if a special type of imaging test, a positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate cancer (CRPC). This PET scan will be combined with a computed tomography (CT) scan taken during the same imaging session. The other purpose of the PET-CT scan using [C-11] acetate (PET Acetate Scan) is to assist in identifying who is responding to the treatment (docetaxel chemotherapy).

Read the detailed description

The purpose of the current pilot clinical trial is to attempt to identify the safety and accuracy of PET-acetate imaging in the assessment of response of persons undergoing first-line docetaxel for CRPC. If successful, the current research could lead to the incorporation of PET-acetate into future study protocols where continuation of chemotherapy is based on early PET-acetate results, provided that effective second-line therapy options are available (which is an expectation for the near future, based on several ongoing and presented phase III trials).

Being tested
PET Acetate scan, Carbon-11 labeled Acetate
Keywords
Castrate resistant, Prostate cancer, Docetaxel, Taxotere, PET 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.

  • PET Acetate scanRadiation

    PET Acetate scans will be done to detect prostate cancer lesions.

  • Carbon-11 labeled AcetateDrug

    Also called C-11 Acetate; Acetate

    C-11 Acetate is a radiotracer used in PET scanning

Study groups in NCT01144897
Study groupRoleWhat they receive
PET Acetate Imaging with DocetaxelExperimentalPET-acetate as an intermediate endpoint in the assessment of response of patients undergoing docetaxel for hormone refractory prostate cancer (HRPC). Subjects will be treated with docetaxel, 75 mg/m2 every 21 days until disease progression or unacceptable toxicity occurs. Subjects will have two PET acetate scans - one prior to beginning chemotherapy and one approximately 8-9 weeks after chemotherapy has begun.
Receives: Radiation: PET Acetate scan; Drug: Carbon-11 labeled Acetate

What is being measured

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

  1. Interpretation of PET Acetate scans

    Standardized uptake values (mean and maximum SUVs) will be determined over the prostate bed and over any acetate-avid or CT-identified suspicious lesions. The change in these SUVs with treatment will be assessed, as well as the number of lesions. A blinded second reviewer from Nuclear Medicine will reviewed all baseline and response PET-acetate scans.

    Measured: Time of enrollment up to one year

Secondary outcomes (1)

  1. Prostate cancer response to treatment and progression (excluding PET Acetate assessment)

    Correlation with chemotherapy response

    Measured: Time of enrollment up to two years

Timeline

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

  1. First posted16 Jun 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionNov 2011
  4. Study completionSep 2018

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
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144897
Sponsor's protocol ID
201002720
Status last verified
Sep 2018
First submitted
14 Jun 2010
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PET Acetate scan and Carbon-11 labeled Acetate in people with Castrate Resistant Prostate Cancer and Prostate Cancer, run by Daniel Vaena at 1 site 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 21 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: finished, as of the sponsor's last update on 2 Oct 2018. 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 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Interpretation of PET Acetate scans (time frame: Time of enrollment up to one year). 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 NCT01144897.

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 2 Oct 2018.

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