Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Prostate Cancer
  • Prostatic Neoplasms
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Background: Radiation therapy is a commonly used therapy for prostate cancers. The majority of men with prostate cancer will be cured by therapy; however a subset, typically men with bulky or higher risk disease will develop PSA failure after definitive radiotherapy. Currently, men with a rising PSA...

Background: Radiation therapy is a commonly used therapy for prostate cancers. The majority of men with prostate cancer will be cured by therapy; however a subset, typically men with bulky or higher risk disease will develop PSA failure after definitive radiotherapy. Currently, men with a rising PSA after radiotherapy may receive hormonal therapy or may undergo further evaluation for local failure. It is not known how many men with rising PSA after radiotherapy may have a local failure and would benefit from a salvage local therapy. With the availability of a growing number of local salvage options, accurately defining the presence and characteristics of local failure is critical. Objective: To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies Eligibility: Patients with no local therapy for prostate cancer: Age greater than or equal to 18 years Histologically confirmed adenocarcinoma of the prostate Intermediate or high risk prostate cancer (clinical stage greater than or equal to T2b, Gleason score 7 or higher, or PSA greater than10, extracapsular extension or seminal vesicle invasion on MRI). Patient will be treated with radiotherapy for prostate cancer. ECOG performance status less than or equal to 2 Patients with biochemical relapse after radiotherapy for prostate cancer: Evidence of prostate cancer recurrence (palpable abnormality after radiotherapy, radiographic evidence of local failure, biochemical relapse) ECOG performance status less than or equal to 2 Age greater than or equal to 18 years Histologically confirmed adenocarcinoma of the prostate Design: Patients with untreated prostate cancer: Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, liver transaminases, PSA, PT/PTT), and imaging studies (as appropriate to staging). Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research) Patients will receive radiotherapy at NIH or at an outside facility. Patients will return for follow up at 3 month intervals for the first 2 years and then every six months for 5 years for PSA measurement. Patients will undergo a multiparametric MR at 6 months after therapy. No biopsy is obtained unless patients meet the definition of treatment failure. This study would allow future correlation with early changes that may predict for eventual outcome. Patients with a rising PSA that meet the criteria for biochemical failure by the Phoenix definition will undergo repeat multiparametric prostate MRI with biopsy of suspicious lesions (diagnostic and research). Patients with recurrent prostate cancer: Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, Liver transaminases, PSA, PT/PTT), and imaging studies. Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research) 120 patients with untreated prostate cancer and 70 patients with biochemical recurrence after radiotherapy will be accrued to this study.

Tracking Information

NCT #
NCT01834001
Collaborators
Not Provided
Investigators
Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)