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

This study is currently recruiting participants.
Verified May 2017 by Chunhee Richard Choo, M.D., Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT03017794
First Posted: January 11, 2017
Last Update Posted: May 24, 2017
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.
Information provided by (Responsible Party):
Chunhee Richard Choo, M.D., Mayo Clinic
  Purpose
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
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Chunhee Richard Choo, M.D., Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 125
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)
Groups/Cohorts
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are to receive either definitive RT +/- ADT as a primary therapy or salvage RT +/- ADT as a salvage therapy for a biochemical relapse with local recurrence in the prostatic fossa following a radical prostatectomy.
Criteria

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
Information from the National Library of Medicine

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


Contacts
Contact: Clinical Trials Referral Office 855-776-0015

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Chunhee Richard Choo, M.D., Radiation Oncology Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03017794     History of Changes
Other Study ID Numbers: 16-008637
First Submitted: January 9, 2017
First Posted: January 11, 2017
Last Update Posted: May 24, 2017
Last Verified: May 2017

Keywords provided by Chunhee Richard Choo, M.D., Mayo Clinic:
Radiotherapy
Chromogranin A
Neuroendocrine differentiation