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

NCT00282906 | Completed DMC

• 1 other identifier: 4P-05-1
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PET/CT imaging validity

  every 4 months

Secondary Outcomes (1)

• Response

  every 4 months

Study Arms (1)

PET-CT

EXPERIMENTAL

Device: hybrid PET-CT imaging system

Interventions

hybrid PET-CT imaging system DEVICE

15 mCi of FDG

PET-CT

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age \> 21 years, men of all ethnic backgrounds
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• 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.

  PMID: 23785174 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hossein Jadvar, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2006
• First Posted: January 27, 2006
• Study Start: October 3, 2005
• Primary Completion: December 19, 2013
• Study Completion: August 19, 2014
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)