Prostate Biomarker Study

Completed

Conditions studied: Prostate Cancer

In brief

Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent outcomes for patients with localized (confined to one area) disease, yet there is still no effective treatment once the disease has spread beyond the prostate gland. Typically, a serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and other tests help to classify the patient's disease according to the likelihood of a recurrence. However, these assessments are imperfect. There is a need to identify and evaluate prostate biomarkers that will provide exact information regarding the likelihood of a recurrence (prediction) of prostate cancer.

Key facts

Study ID

NCT00574899

Run by

Memorial Sloan Kettering Cancer Center

People needed

32

Starts

2007-05-01

Expected to finish

2011-05-01

Last updated by the study team

2015-10-20

Who can join

Age: 35 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males, 35 years of age or older, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland.
• Biopsy performed at the SPORE institution.
• No prior therapy for prostate cancer (patients who receive neoadjuvant therapy after collection of blood and biopsy samples are eligible).
• The patient should have 2 or more cores involved with carcinoma. The minimum amount of tumor submitted should be 5 mm, or at least 40% of the core involved with tumor. (This amount can be made up from 2 positive cores if 1 core is insufficient).
• Patients with clinical stage T1-T2a NXM0 prostate cancer who elect to be treated with RP or XRT (includes external beam radiation, brachytherapy, or both) at the SPORE institution.
• Patients with a nomogram predicted 5-year probability of freedom from biochemical recurrence (Kattan 1998) of less than or equal to 85% (patients with intermediate risk of recurrence).
• Ability and willingness to sign informed consent

You may not qualify if…

• Participation in a therapeutic clinical trial with an experimental agent.
• Previous cancer of any kind except non-melanoma skin cancer
• Previous surgical or minimally invasive treatment for enlarged prostate (e.g. TURP, TUNA, TUIP, laser, microwave)
• Use of anti-androgen drugs during the 6 months prior to diagnosis
• Use of 5-alpha-reductase inhibitors during the 6 months prior to diagnosis

Where it is running

• UCLA — Los Angeles, California, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.