Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Prostate Cancer Patients Who Have Brachytherapy Seed Implant; Prostate Cancer Patients Treated by Radiotherapy; Prostate Cancer Recurrent; Prostate Cancer (Diagnosis)

Study type: Observational

Funder types: Other

Identifiers

NCT07131956

ImmunBioProBrachy

Details and patient eligibility

About

Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Arm 1:

• Primary treatment with I-125 seeds or HDR-BT
• No previous treatment for prostate cancer
• Age ≥ 18 years

Inclusion Criteria Arm 2:

• HDR- or PDR-BT
• No radiation therapy within three months before salvage treatment
• Complete documentation available on previous treatment for prostate cancer
• No history of prostatectomy
• Age ≥ 18 years

Exclusion Criteria:

• Pre-existent auto-immune disease
• patients under bloodthinning medication
• substance abuse

Trial design

200 participants in 2 patient groups

Primary brachytherapy

Description:

Patients receiving sole primary brachytherapy (either LDR-BT or HDR-BT) for low or low intermediate risk prostate cancer

Salvage brachytherapy

Description:

Patients receiving sole brachytherapy (either PDR-BT or HDR-BT) for locally recurrent prostate cancer after prior irradiation with prostate in situ