Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy in Prostate Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/20/2018 |
| Start Date: | January 2017 |
| End Date: | December 2020 |
| Contact: | Clinical Trials Referral Office |
| Phone: | 855-776-0015 |
This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A
(CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT)
is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is
measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a
definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time
points. The study will analyze the followings: 1. Change in CgA level at various pre-defined
post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA
change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA
change and treatment outcome.
(CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT)
is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is
measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a
definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time
points. The study will analyze the followings: 1. Change in CgA level at various pre-defined
post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA
change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA
change and treatment outcome.
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.
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.
Inclusion Criteria:
- Clinically localized prostate carcinoma, T1-T4 N0M0, any Gleason Score, any
prostate-specific antigen (PSA), or Biochemical relapse with clinically suspicious
(based on MRI or clinical examination) or biopsy-proven local recurrence in the
prostatic fossa after a radical prostatectomy
- ≥18 years old
- Histologic diagnosis of prostate adenocarcinoma
- Signed informed consent
Exclusion Criteria:
- Biochemical relapse alone without clinically suspicious (i.e. no suspicious lesion on
MRI of the prostatic bed) or biopsy-proven local recurrence in the prostatic fossa
- Regional pelvic node metastasis (N1)
- Distant metastasis (M1)
- Concurrent or previous cytotoxic medications
- Medical or psychological conditions that in the opinion of the investigator would not
allow follow-up
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