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Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer
Plain-language guide to NCT00669162: phase 1, phase 2 interventional trial of Leuprolide and Goserelin, 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00669162
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2012-08
- Completion (planned or actual)
- 2016-08
- Participants
- 27 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Leuprolide and Goserelin.
It had 1 arm (groups): RT, Docetaxel, Hormonal Therapy (experimental).
The registry classes the interventions as drug and radiation.
More on the Plan
After consent, laboratory and radiologic tests will be done and a baseline questionnaire will be completed.
Participants will then be started on the protocol specific hormonal therapy for a total of 6 months.
After 2 months of hormone therapy the participants will begin radiation therapy and concurrent docetaxel chemotherapy treatments.
Participants will receive docetaxel once a week for a total of 7 infusions with concurrent radiation therapy treatments.
Who Took Part
The registry lists 27 actual participants took part.
It was open to men only aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 42 exclusion criteria; among the exclusions: histologically documented adenocarcinoma of the prostate; pathologic tumor 2-node 0 (t2n0) disease with positive margins and gleason score ≥8, or; pathologic tumor 3a-node 0 t3an0 disease with extracapsular extension and gleason score ≥ 8, or.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-08 with completion listed for 2016-08.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Leuprolide and Goserelin in 27 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Leuprolide compound page and the Goserelin compound page, all human trials.
Our Notes on the Compounds
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.
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
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.