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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Clinically localized prostate carcinoma, T1-T4 N0M0, any Gleason Score (Gleason Score 7 including those with T3 disease as well as ≤ T2c disease), 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Chunhee Choo, M.D.	Closed for enrollment	Contact information: Adam Amundson (507)293-1826 Amundson.Adam1@mayo.edu
Jacksonville, Fla. Mayo Clinic principal investigator Bradford Hoppe, M.D., M.P.H.	Closed for enrollment	Contact information: Anna Harrell M.P.H. (904)953-8183 Harrell.Anna@mayo.edu
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Carlos Vargas, M.D.	Closed for enrollment	Contact information: Courtney James (480)342-2465 James.Courtney1@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Chunhee Choo, M.D.

Closed for enrollment

Contact information:

Adam Amundson

(507)293-1826

Amundson.Adam1@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Bradford Hoppe, M.D., M.P.H.

Closed for enrollment

Contact information:

Anna Harrell M.P.H.

(904)953-8183

Harrell.Anna@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Carlos Vargas, M.D.

Closed for enrollment

Contact information:

Courtney James

(480)342-2465

James.Courtney1@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials