Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy in Prostate Carcinoma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- 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 ]
|Actual Study Start Date:||January 2017|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03017794
|Contact: Clinical Trials Referral Office||855-776-0015|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|