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Prostate CancerNCT00282906

FDG Positron Emission Tomography and Computed Tomography (PET-CT) in Metastatic Prostate Cancer

A study testing hybrid PET-CT imaging system in people with Prostate Cancer, run by University of Southern California 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

This is an National Institute of Health (NIH) funded, investigator-initiated, single center prospective study to investigate the ability of the new dual-modality positron emission tomography and computed tomography (PET-CT) imaging systems in comparison to conventional imaging methods in assessing treatment response… Read more about this study

Who is it for?
Ages 21 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
hybrid PET-CT imaging system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
1 siteUnited States
Study dates
3 Oct 2005to 19 Aug 2014
Phase
Interventional
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 21 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Group-I (hormone-responsive) inclusion criteria:
  • Age > 21 years, men of all ethnic backgrounds
  • Patient must have had a histological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is hormone- naïve received prior to the development of objective evidence for MACRO metastatic or recurrent disease (e.g. during biochemical PSA relapse without imaging evidence of disease).
  • Evidence of metastatic disease must be documented as: conventional imaging evidence for metastatic disease as determined by CT, bone scintigraphy, or both (Note: although there are no strict windows for obtaining other scans bone, CT) relative to the timing of the PET scans, every effort will be made to have these 'standard' scans obtained within 3 months of the Baseline PET scan
  • Group-II (hormone-refractory) inclusion criteria:
  • Age > 21 years, men of all ethnic backgrounds
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  • Patients must have received prior hormonal therapy. Patients treated with orchiectomy are eligible.
  • Patient must have had a histological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormonal therapy. Evidence of unresponsive or refractory disease must be documented by either:
  • a progression of disease assessed with CT or bone scan or as judged clinically based on factors such as increasing bone pain (Note: although there are no strict windows for obtaining other scans (bone, CT) relative to the timing of the PET scans, every effort will be made to have these 'standard' scans obtained within 3 months of the PET scan) OR
  • a rising serum PSA level - defined as at least 2 consecutive rises in PSA documented over a reference value (1st measure within 3 months prior to recruitment); The first rising PSA (2nd measure) should be taken at least 14 days after the reference value. A confirmatory PSA measure (3rd measure) should be obtained at least 14 days after the 2nd measure and must be greater than the 2nd measure. Additionally, patient must have a serum PSA concentration of at least 2 ng/mL in addition to increasing PSA to be eligible. However, if the patient is clinically judged to have progressive disease irrespective of PSA (e.g. metastasis-related bone pain, clear increase in lesions evident on a bone scan and/or CT if available), documenting a minimum or rising PSA level would not be required.
  • Other general inclusion criteria for both groups:
  • If the treating physician has determined that the patient is not clinically responding to the current therapy prescribed and, in the best interest of the patient, the physician plans to change the treatment to a new treatment.
  • Example: a Group I patient currently treated with a form of anti-androgen therapy which is not responding; the patient can be considered for enrollment into the PET-CT imaging study prior to a new anti-androgen therapy even though he was treated with anti-androgen therapy before. The wait time between the end of old therapy and the beginning of the new therapy is based entirely on clinical judgment
  • Example: a Group II patient currently treated with a form of therapy for hormone refractory disease (chemo) therapy which is not responding; the patient can be considered for enrollment into the PET-CT imaging study prior to a new therapy even though he was treated with chemotherapy another type of hormone-refractive therapy before. The wait time between the end of old therapy and the beginning of the new therapy is based entirely on clinical judgment
  • May have received prior surgery (14 days must have elapsed since completion of surgery with recovery from side effects)
  • Creatinine ≤ 2.5 x the institutional upper limit of normal (within 28 days prior to enrollment)
  • Men of childbearing potential must be willing to consent to use effective contraception.
  • Must be competent to consent to study requirements
  • Patients may also be enrolled in the study from either group if the therapeutic regimen (hormone therapy or chemotherapy and/or other therapies for hormone refractory disease has been administered for up to 2 weeks prior to the baseline PET scan.
  • OPTIONAL: Completed analgesic pain survey. If unable to complete questionnaires in English or Spanish, patient can still participate in this study.

Who cannot join

  • History of cancer other than prostate cancer (except squamous cell carcinoma of the skin that has been treated with curative intent) or other cancers clinically judged to be cured or inactive based on history, physical examination, tumor markers, or imaging findings.
  • Active infection (except mild upper respiratory infections or other sites if clinically judged not to interfere with image interpretation on a per case basis)
  • History of poorly-controlled diabetes mellitus (with Fasting Blood Glucose greater than 200 mg/dL) - in order to avoid false negative results due to glucose competition with [F-18]-Fluorodeoxyglucose in cellular uptake
  • Active inflammatory conditions (e.g. rheumatoid arthritis, sarcoid)
  • History of complicated non-healing fracture
  • Not competent to consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: [F-18]-Fluorodeoxyglucose (FDG) Positron Emission Tomography and Computed Tomography (PET-CT) in Metastatic Prostate Cancer

This is an National Institute of Health (NIH) funded, investigator-initiated, single center prospective study to investigate the ability of the new dual-modality positron emission tomography and computed tomography (PET-CT) imaging systems in comparison to conventional imaging methods in assessing treatment response in men with metastatic prostate cancer. The investigators will enroll two groups of men with stage IV metastatic prostate cancer, each group will be comprised of 160 patients.

  • Group I: men with newly diagnosed hormone-responsive measurable metastatic disease who will be treated with androgen-ablation therapy
  • Group II: men with newly-developed hormone-refractory measurable metastatic disease who will be treated with chemotherapy and /or other therapies for hormone refractory disease

To be eligible, men in either group must have rising serum prostate specific antigen (PSA) level - defined as at least 2 consecutive rises in PSA documented over a reference value (1st measure within 28 days prior to recruitment). The first rising PSA (2nd measure) should be taken at least 14 days after the reference value. A confirmatory PSA measure (3rd measure) obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd measure. Additionally, patients must have a serum PSA concentration of at least 2 ng/mL in addition to increasing PSA to be eligible. Patients will be followed with the PET-CT at 4, 8, and 12 months after the initiation of androgen ablation therapy (Group I) or chemotherapy (Group II).

Read the detailed description

Our long-range objective is to obtain pilot data to investigate the ability of the new dual-modality positron emission tomography and computed tomography (PET-CT) imaging systems for assessing treatment response in patients with metastatic prostate cancer in comparison to conventional imaging. PET-CT is not employed here for staging; all men in this study will have stage IV metastatic prostate cancer. We believe that the combined anatomic and in-vivo metabolic imaging information provided by PET-CT allows accurate objective assessment of such critical clinical issues as early prediction and evaluation of response or resistance to various therapeutic interventions, including the novel chemotherapy regimen, as well as the prediction of key clinical outcomes such as time to hormone-refractoriness and survival. Our intermediate-range objective is therefore to investigate the diagnostic and prognostic utility of PET-CT with the most commonly available PET tracer, [F-18]-fluorodeoxyglucose (FDG), in metastatic prostate cancer. We plan to correlate the treatment-induced changes of glucose metabolism in metastatic prostate cancer lesions to the changes in various conventional clinical, laboratory, and diagnostic imaging parameters such as serum prostate-specific antigen level, lesion size, time to androgen independence, and survival. This objective is motivated by our preliminary basic science and clinical data as well as the published reports of other investigators demonstrating the pragmatic potential diagnostic and prognostic utility of FDG PET-CT in men with metastatic prostate cancer.

Conditions
Prostate Cancer
Being tested
hybrid PET-CT imaging system
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • hybrid PET-CT imaging systemDevice

    15 mCi of FDG

Study groups in NCT00282906
Study groupRoleWhat they receive
PET-CTExperimentalNot described
Receives: Device: hybrid PET-CT imaging system

What is being measured

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

  1. PET/CT imaging validity

    Measured: every 4 months

Secondary outcomes (1)

  1. Response

    Measured: every 4 months

Timeline

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

  1. First posted27 Jan 2006 (estimated)
  2. Study start3 Oct 2005
  3. Primary completion19 Dec 2013
  4. Study completion19 Aug 2014

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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00282906
Sponsor's protocol ID
4P-05-1
Status last verified
Apr 2017
First submitted
25 Jan 2006
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jadvar H, Desai B, Ji L, Conti PS, Dorff TB, Groshen SG, Pinski JK, Quinn DI. Baseline 18F-FDG PET/CT parameters as imaging biomarkers of overall survival in castrate-resistant metastatic prostate cancer. J Nucl Med. 2013 Aug;54(8):1195-201. doi: 10.2967/jnumed.112.114116. Epub 2013 Jun 19.

    PubMed 23785174

Questions about this trial

What is this clinical trial studying?

A study testing hybrid PET-CT imaging system in people with Prostate Cancer, run by University of Southern California 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 20 inclusion and 6 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 18 Apr 2017. 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.

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?

PET/CT imaging validity (time frame: every 4 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 NCT00282906, 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 18 Apr 2017.

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