Prostate Caner
Conditions
Interventions
Gold Standard:Histological or cytological examination
Index test:nuclear imaging
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older and willing and to be able to provide informed consent 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features; 3. Confirmed castration resistant prostate cancer at high risk for the development of metastasis, which was defined as a PSA doubling time of 10 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists); 4. No prior or present evidence of metastatic disease as assessed by CT/MRI for soft tissue disease and whole-body radionuclide bone scan for bone disease. If the screening bone scan shows a lesion suggestive of metastatic disease, the patient will be eligible only if a second imaging modality (plain film, CT, or MRI) does not show bone metastasis. If the imaging results are equivocal or consistent with metastasis, the patient is not eligible for enrollment. Patients with soft tissue pelvic disease may be eligible if lesions do not qualify as target lesions (eg, lymph nodes below aortic bifurcation are permissible if the short axis of the largest lymph node is < 15 mm); 5. ECOG=1; 6. Estimated life expectancy = 12 months.
Exclusion criteria
Exclusion criteria: 1. History of another invasive cancer within 3 years of enrollment, with the exception of fully treated cancers with a remote probability of recurrence in the opinion of both the medical monitor and investigator; 2. Any prior medical history that according to the judgement of the investigator might interfere with the subject's granting of informed consent or the safe execution of the procedures required in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radiologic heterogeneity between lesions detected by nuclear imaging including local/pelvic disease and distant metastatic (M1) disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| correlation of radiologic findings with survival and treatment outcomes; | — |
Contacts
Public ContactDingwei Ye
Fudan University Shanghai Cancer Center
Outcome results
None listed