Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy

Status unconfirmed

Conditions studied: Prostate Cancer

In brief

The goal of this clinical research study is to create a registry (research database) of clinical data about patients who receive radiation therapy, with or without hormone therapy, to treat prostate cancer that has come back after surgical removal of the prostate. This treatment is standard and the actual treatment is not part of this protocol. The goal of this clinical research study is to create a registry (research database) of clinical data about patients who receive radiation therapy, with or without hormone therapy, to treat prostate cancer that has come back after surgical removal of the prostate. This treatment is standard and the actual treatment is not part of this protocol. Researchers want to collect data and use this registry to learn about the long-term status of prostate cancer after these treatments. This is an investigational study. Up to 500 patients will take part in this study. All will be enrolled at MD Anderson, Spartanburg Regional Healthcare System, and/or MD Anderson Cancer Center Albuquerque. Researchers want to collect data and use this registry to learn about the long-term status of prostate cancer after these treatments.

Key facts

Study ID

NCT00850941

Run by

M.D. Anderson Cancer Center

People needed

146

Starts

2009-01-26

Expected to finish

2021-01-01

Last updated by the study team

2019-05-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adenocarcinoma of the prostate definitively treated by radical prostatectomy.
• Patients must have no evidence of nodal or distant metastasis by clinical and radiologic staging to include bone scan and CT scan or MRI of the abdomen and pelvis. Patients with clinical or radiographic local recurrence are eligible. In patients with Gleason score less than or equal to 7 and PSA less than or equal to 1, CT or MRI of the abdomen is recommended but not required.
• Rising PSA after prostatectomy defined as at least 2 consecutive rises. If total PSA < 0.2 ng/ml, surgical pathology must also show extracapsular extension, positive margins, or seminal vesicle involvement.
• Total PSA < 5 ng/ml within 12 weeks prior to starting radiation or hormone therapy.
• Patients with PSA greater than or equal to 0.5 ng/ml may have up to 3 months of an LHRH agonist and an anti-androgen immediately prior to enrollment.
• All patient must have a serum testosterone of 150 ng/dl or greater documented prior to initiation of hormone therapy. Alternatively, patients without documentation of serum testosterone prior to initiation of hormone therapy should not have had any other prior hormone therapy within the 24 months preceding initiation of hormone therapy.

You may not qualify if…

• Patients with pathologically positive pelvic lymph nodes at prostatectomy.
• Patients with positive prostascint scans outside prostatic fossa.
• Any chemotherapy, immunotherapy, biological therapy for cancer within 90 days of enrollment.
• Hormone therapy (specifically LHRH agonist or antagonist, non-steroidal or steroidal antiandrogens) of more than 6 months duration at any time in the past for prostate cancer.
• Contraindications to external beam radiation therapy to include previous pelvic radiation, inflammatory bowel disease or history of collagen vascular disease.

Where it is running

• Kaseman Presbyterian Hospital — Albuquerque, New Mexico, United States
• Spartanburg Regional Healthcare System — Spartanburg, South Carolina, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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