C-Acetate PET/CT Imaging to Evaluate Treatment Changes in Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/30/2018 |
| Start Date: | March 2016 |
| Contact: | Dan Pryma, MD |
| Email: | PennCancerTrials@emergingmed.com |
| Phone: | 855-216-0098 |
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
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
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.
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Dan Pryma, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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