Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy
1 other identifier
observational
146
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2009
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2009
CompletedFirst Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMay 15, 2019
May 1, 2019
10.9 years
February 23, 2009
May 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Registry (research database)
Analyze data annually beginning once 100 patients have 1 year of follow-up; Anticipate annual enrollment of 100 patients.
Secondary Outcomes (1)
Quality of Life Assessment
At the 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year follow-up visits.
Study Arms (1)
Questionnaire
Prognostic factors and outcome for patients treated with radiation with curative intent for rising Prostate Specific Antigen (PSA) post-prostatectomy.
Interventions
Information collection.
Eligibility Criteria
Patients having a rising prostate-specific antigen (PSA) level after prostate was surgically removed, meaning prostate cancer return.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kaseman Presbyterian Hospital
Albuquerque, New Mexico, 87110, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
Leftover tissue from prostate surgery to be used for biomarker research.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah A Kuban, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 25, 2009
Study Start
January 26, 2009
Primary Completion
January 1, 2020
Study Completion
January 1, 2021
Last Updated
May 15, 2019
Record last verified: 2019-05