Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome

Men with biopsy-proven, non-metastatic prostate adenocarcinoma, meeting the inclusion/exclusion criteria below, and electing to undergo definitive radiation treatment, will be eligible for participation.

Women with biopsy-proven, non-metastatic invasive or in situ breast cancer meeting the inclusion/exclusion criteria below will be eligible for participation.

Cohort 1a and b: Prostate cancer subjects undergoing 9 week radiation

Inclusion criteria:

• Biopsy-proven diagnosis of prostate adenocarcinoma
• Age ≥ 18

Exclusion criteria:

• History of prior pelvic radiation (external beam or brachytherapy)
• Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years
• History of hormone therapy such as LHRH agonists (gosrelin, leuprolide), anti-androgens (flutamide, bicalutamide), surgical castration (orchiectomy)
• History of irritable bowel disease
• Evidence of lymph node involvement or metastatic disease

Cohort 2a : Breast cancer subjects undergoing standard fractionation RT of 5 weeks

Inclusion criteria:

• Biopsy-proven diagnosis of invasive breast cancer, s/p breast surgery to negative margins, and requiring adjuvant breast and nodal RT
• Age ≥ 18

Exclusion criteria:

• History of prior radiation therapy to the ipsilateral breast
• Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years
• \< 1 month from completion of chemotherapy to start of RT
• Evidence of metastatic disease

Cohort 2b: Breast cancer subjects undergoing PBI

Inclusion criteria:

• Post-menopausal women defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status.
• Post-segmental mastectomy with negative margins
• If bilateral, pT1 breast cancer, excised with negative margins AND/OR
• pTis excised with negative margins
• Clinically N0 or pN0 or sentinel node negative
• Diagnosis of ductal carcinoma in situ DCIS, limited to \<2cm size of DCIS and to lesions of low or intermediate grade, excised (or re-excised) with final negative margins ( no DCIS on inked margins).
• Age ≥ 18

Exclusion criteria:

• History of prior radiation therapy to the ipsilateral breast
• Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC).
• \< 1 month from completion of chemotherapy to start of RT
• Evidence of metastatic disease