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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715583
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Patients Drug: 11C-Acetate Drug: Ra-223 therapy Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: C-Acetate PET/CT Imaging to Evaluate Treatment Changes in Prostate Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria at least 18 years of age
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715583


Contacts
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Contact: Dan Pryma, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19004
Contact: Dan Pryma, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Dan Pryma, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Dan Pryma, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02715583    
Other Study ID Numbers: UPCC 02816
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases