← Human Trials & Peer-Reviewed Studies
Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
Plain-language guide to NCT00631527: phase 1 interventional trial of Leuprolide and Goserelin, 19 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00631527
- Phase
- phase 1
- Status
- completed
- Start
- 2008-02
- Completion (planned or actual)
- 2015-01
- Participants
- 19 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Leuprolide and Goserelin.
It had 1 arm (groups): Sunitinib Malate, Hormone Ablation + RT (experimental).
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT).
The registry classes the interventions as drug and radiation.
More on the Plan
Luteinizing Hormone-Releasing Hormone (LHRH) Analogues like Lupron® (leuprolide) and Zoladex® (goserelin) are hormonal treatments used to help stop the body from making testosterone (male sex hormones) in the body.
Anti-Androgen drugs, like Casodex® (bicalutamide) also stop cell growth by blocking male hormones like testosterone.
Study Drug Administration: If you are found to be eligible to take part in this study, you will be assigned to a study group.
Before you begin taking sunitinib, you will begin receiving hormone therapy.
Who Took Part
The registry lists 19 actual participants took part.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: prior vegfr/pdgfr inhibitor or other investigational therapy; inability to take oral medication; known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Leuprolide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2008-02 with completion listed for 2015-01.
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 trial of Leuprolide and Goserelin in 19 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.