C-Acetate PET/CT Imaging to Evaluate Treatment Changes in Prostate Cancer

NCT02715583 | Completed Early Phase 1 DMC

• 1 other identifier: UPCC 02816
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer \[11C\]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy

Conditions

Prostate Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Estimate the fold change in SUVmax ()

  • Estimate the fold change in SUVmax () of selected index lesions and the sum of SUVmax over the most 11C-acetate avid lesions, up to five, measured at pre and post Ra-223 dichrolide therapy.

  1 year

Study Arms (1)

Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease.

EXPERIMENTAL

Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer \[11C\]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy Patients will also undergo serial lab tests (PSA, and alkaline phosphatase levels). If these tests are done as part of clinical standard of care they will not need to be repeated for this study. Patients will be asked to complete a quality of life metric (short form of the McGill pain questionnaire) on the day of each PET/CT scan.

Drug: 11C-Acetate

Interventions

11C-Acetate DRUG

Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease.

Eligibility Criteria

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

You may qualify if:

• History of biopsy proven or clinically documented castrate resistant prostate cancer which is metastatic to bone as assessed by medical record review.
• Patients selected for Ra-223 dichloride therapy for treatment of bone metastasis by their treating physician.
• Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

You may not qualify if:

• Not on current androgen deprivation therapy or plan for withdrawal of androgen deprivation therapy
• Cytotoxic chemotherapy within 4 weeks prior to study enrollment
• Systemic radioisotope therapy within 24 weeks prior to study enrollment
• Eminent or established cord compression as assessed by medical record review
• History of hemibody external radiotherapy as assessed by medical record review
• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• Serious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
• Documented visceral metastases or current lymphadenopathy \> 3 cm by standard imaging (e.g. MRI, CT, ultrasound, FDG PET/CT)
• Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Women, children, fetuses, neonates, or prisoners are not included in this research study.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19004, United States

Location

MeSH Terms

Interventions

carbon-11 acetate

Study Officials

• Dan Pryma, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2016
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: May 18, 2022

Record last verified: 2020-11

Locations

US (1)