C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01530269

Enrollment

300

Registered

2012-02-09

Start date

2012-04-30

Completion date

2019-01-31

Last updated

2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma, Prostate Cancer

Keywords

intermediate, high, risk, radiation, therapy, planning, surgical, immunotherapy, chemotherapy, hormone

Brief summary

Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.

Detailed description

OBJECTIVES: * Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy. * Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

Interventions

DRUGC11-Sodium Acetate

PET Imaging with C11-Sodium Acetate

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Male patients will be studied who have prostate cancer: * Diagnosed with prostate adenocarcinoma * Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery * Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following: * Gleason score \>= 7 or PSA \>= 10 * Gleason score \< 7 or PSA \<10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy * Rising or non-responding PSA

Exclusion criteria

* \< 18 years old * claustrophobic patients

Design outcomes

Primary

Measure	Time frame	Description
Tissue Biopsy of metastatic site(s)	Assessed within 30 days following AC-PET	Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT

Secondary

Measure	Time frame	Description
PSA (prostate specific antigen)	Each 3 - 6 months for 24 months	PSA (prostate specific antigen) will be monitored per routine clinical follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026