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Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03017794
Collaborator
(none)
125
Enrollment
1
Location
71
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    125 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Correlate the extent of post-RT CgA change with Gleason score of malignancy [18 months]

    2. Correlate the extent of post-RT CgA change with treatment outcome, using biochemical recurrence as an endpoint [60 months]

    Secondary Outcome Measures

    1. Examine the extent of CgA change at various post-RT time points [18 months]

    2. 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 [18 months]

    3. Compare the extent of post-therapy CgA change between patients receiving photon-based RT and those undergoing proton-based RT [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: C. Richard Choo, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Chunhee Richard Choo, M.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03017794
    Other Study ID Numbers:
    • 16-008637
    First Posted:
    Jan 11, 2017
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chunhee Richard Choo, M.D., Principal Investigator, Mayo Clinic
    Radiotherapy
    Chromogranin A
    Neuroendocrine differentiation
    Additional relevant MeSH terms:
    Recurrence

    Study Results

    No Results Posted as of Jan 28, 2022