prospective monitoring of subjects with biochemically recurrent prostate cancer using 18fdcfpyl

Conditions: Prostate Cancer; Biochemically Recurrent

Summary: background: prostate cancer is the second leading cause of cancer-related death in american men. the disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. in this natural history study, researchers want to find out if a new radiotracer (18f-dcfpyl) injected before positron emission tomography (pet) imaging can help identify sites in the body with cancer. objective: to learn more about how 18f-dcfpyl pet/ct scans detect change over time in men with recurrent prostate cancer. eligibility: men aged 18 and older with prostate cancer that returned after treatment. design: participants will be screened with blood tests. they will also have a bone scan and a computed tomography (ct) scans of the chest, abdomen, and pelvis. participants will have an initial study visit. they will have a physical exam and blood tests. they will have a pet/ct scan with 18f-dcfpyl. the radiotracer will be injected into a vein; this will take about 20 seconds. the pet/ct scan will be done 1 to 2 hours later. participants will lie still on a scanner table while a machine captures images of their body. the scan will take 45 minutes. participants will return for blood tests every 3 months. participants will return for additional scans with 18f-dcfpyl on this schedule: once a year if their previous scan was negative for prostate cancer. every 6 months if their previous scan was positive for prostate cancer. participants may be in the study up to 5 years.

background: * prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in american men. * about 25,000 to 50,000 men each year develop a rising prostate-specific antigen (psa) after definitive radiation or surgery for early-stage disease but have negative findings on computed tomography (ct) and tc99 bone scan (standard imaging in prostate cancer). * the recent food and drug administration (fda) approval of 18f-dcfpyl pet imaging provides an opportunity to locate micrometastatic lesions in patients with recurrent disease. * it is unknown how these lesions (or prostate cancer) evolve over time in men with positive findings on 18f-dcfpyl pet imaging. objective: -to observe participants with biochemically recurrent prostate cancer for 5 years to understand the evolution of 18f-dcfpyl pet lesions in this population. eligibility: * history of primary treatment for prostate cancer (either surgery or radiation). * psa \>= 0.50, and testosterone \>100. * age \>=18 years. * no evidence of metastatic soft tissue disease on ct scan (or mri), or bone lesions on bone scan. * no androgen deprivation therapy (adt), no systemic therapy within the 6 months before the study intervention, and no prostatectomy within 1 year before the study intervention. design: * eligible participants will have clinical evaluations and imaging studies. participants with negative findings on initial/following 18f-dcfpyl scan(s) will be invited approximately every year (+/-12 weeks) for follow-up imaging studies (including 18f-dcfpyl pet scans). participants with positive findings on initial/following 18f-dcfpyl scan(s) will be invited approximately every 6 months (+/-8 weeks) for repeat scans, not to exceed 2 scans per year. * after the initial evaluation, participants will be invited to nih approximately every 3 months (+/- 4 weeks) for psa testing.

Eligibility criteria:
* inclusion criteria: * history of primary treatment for prostate cancer (either surgery or radiation) * serum psa \>= 0.50 * serum testosterone \>100 * age \>=18 years * men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable * the ability of a participant to understand and the willingness to sign a written informed consent document exclusion criteria: -evidence of soft tissue disease on ct scan (or magnetic resonance imaging \[mri\] as clinically indicated). note: lymph nodes \<= 1.5 cm in the shortest dimension are allowed. * evidence of bone lesions on tc99 bone scan * prostatectomy within 1 year before the study intervention * androgen deprivation therapy (adt) within the 6 months before the study intervention * systemic therapy for prostate cancer within the 6 months before the study intervention

Keywords: cancer of prostate natural history imaging