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

NCT03017794 | Active Not Recruiting

• 1 other identifier: 16-008637
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

Radiotherapy; Chromogranin A; Neuroendocrine differentiation

Outcome Measures

Primary Outcomes (2)

• Post-RT CgA and Gleason Score (GS)

  Post-RT CgA will be correlated with Gleason score (GS).The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly.

  5 years 6 months

• Chromogranin A (CgA) levels

  Chromogranin A (CgA) levels will be recorded before radiation therapy (RT), during RT, and post-RT.

  5 years 6 months

Secondary Outcomes (3)

• Androgen deprivation therapy (ADT) and CgA

  5 years 6 months

• Post--therapy CgA in photon-based RT and proton-based RT

  5 years 6 months

• CgA and biochemical recurrence

  5 years 6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained for future research with permission of participants

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ryan M. Phillips, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: January 4, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

US (3)