Status:
UNKNOWN
Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
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 c...
Detailed Description
Standard Treatment: If you are found to be eligible and you choose to take part, you will be enrolled in this study. Study participants will be those who are receiving the standard radiation treatmen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 26 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00850941
Start Date
January 26 2009
End Date
January 1 2021
Last Update
May 15 2019
Active Locations (3)
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1
Kaseman Presbyterian Hospital
Albuquerque, New Mexico, United States, 87110
2
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
3
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030