← Human Trials & Peer-Reviewed Studies
Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy
Plain-language guide to NCT00684905: phase 2 interventional trial of Leuprolide, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00684905
- Phase
- phase 2
- Status
- completed
- Start
- 2000-04
- Completion (planned or actual)
- 2005-10
- Participants
- 50 (estimated)
- Design
- treatment
- Conditions studied
- Prostate Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Leuprolide.
Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body.
Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor.
The registry classes the interventions as drug, procedure and radiation.
More on the Plan
OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration.
Patients then undergo interstitial brachytherapy implantation with I-125.
Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.
Quality of life is assessed at baseline and at every treatment and follow-up visit.
Who Took Part
The registry lists 50 planned participants were the target.
It was open to men only.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Biopsy-proven adenocarcinoma of the prostate. Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA). No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis. PSA \< 10 ng/mL. Prostate volume by transrectal ultrasonography \< 60 cc.
The full record lists 18 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was an interventional.
It started in 2000-04 with completion listed for 2005-10.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Feasibility. Patient tolerance. Toxicities.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Leuprolide in 50 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.