Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy in Prostate Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03017794|
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : February 21, 2018
|Condition or disease|
Neuroendocrine differentiation (NED) in prostate cancer is a well-recognized phenotypic change by which prostate cancer cells transdifferentiate into neuroendocrine-like (NE-like) cells. Accumulated evidences have suggested that the prevalence of NE-like cells is associated with disease progression and poor prognosis.
NED can be induced by a therapeutic agent. Such therapeutic agents include RT and ADT. RT-induced NED represents a novel pathway by which prostate cancer cells survive radiotherapy and contribute to treatment failure and tumor recurrence. Chromogranin A is the serum biomarker for NED and correlates well with CgA-positive staining in biopsy specimens. It has been reported that elevated serum CgA is associated with poor therapeutic response, androgen-independent growth, and biochemical recurrence.
The study tests whether the extent of serum CgA increase by RT +/- ADT, which reflects radiation-induced NED, is correlated with the risk of prostate cancer recurrence following RT and a Gleason score of prostate carcinoma.
|Study Type :||Observational|
|Estimated Enrollment :||125 participants|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Gleason score 6 or less
Prostate adenocarcinoma with Gleason score 6 or less
Gleason score 7
Prostate adenocarcinoma with Gleason score 7
Gleason score 8 -10
Prostate adenocarcinoma with Gleason score 8 -10
- Correlate the extent of post-RT CgA change with Gleason score of malignancy [ Time Frame: 18 months ]
- Correlate the extent of post-RT CgA change with treatment outcome, using biochemical recurrence as an endpoint [ Time Frame: 60 months ]
- Examine the extent of CgA change at various post-RT time points [ Time Frame: 18 months ]
- Examine the effect of ADT on CgA level for patients receiving RT + ADT, and Compare the extent of post-therapy CgA change between patients receiving RT alone and those undergoing RT + ADT [ Time Frame: 18 months ]
- Compare the extent of post-therapy CgA change between patients receiving photon-based RT and those undergoing proton-based RT [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017794
|Contact: Clinical Trials Referral Office||855-776-0015|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|