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NCT04775355

Study to Detect Changes in Urinary and Gut Microbiome During Androgen Deprivation Therapy and Radiation Therapy in Patients With Prostate Cancer

Recruiting now Last updated 16 September 2025
What this trial tests

trial testing Biospecimen Collection in Stage I Prostate Cancer AJCC v7 in 30 participants. Currently enrolling.

Timeline
14 April 2021
Primary endpoint
29 July 2026
29 July 2026

Quick facts

Lead sponsorCity of Hope Medical Center
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment30
Start date14 April 2021
Primary completion29 July 2026
Estimated completion29 July 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

City of Hope Medical Center

Who can join

18 and older, male only, with Stage I Prostate Cancer AJCC v7 or Stage II Prostate Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study collects urine and stool samples to determine the ability to identify changes in the microbiome (bacteria, fungi, and viruses that live in the gut and urine) of patients with prostate cancer during androgen deprivation therapy and radiation therapy. Radiation therapy has the potential to harm the genitourinary area or the bowel, causing a feeling of urgency or increased inflammation in the area. The radiation therapy is designed to not irradiate the bowel and bladder areas, but there is still some radiation exposure. The gut microbiome has been associated with differences in inflammation as well as producing molecules that influence healing. The purpose of this study is to see whether the microbiome may contribute to the healing of the organs exposed to radiation. Information learned from this study may help researchers discover a new risk factor that could be manipulated to improve the quality of life in patients with prostate cancer.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Microbiome in Cancer Development and Treatment.
    Ciernikova S, Sevcikova A, Mladosievicova B, Mego M. · · 2023 · cited 16× · PMID 38257851 · DOI 10.3390/microorganisms12010024
  2. The Role of Tumor and Host Microbiome on Immunotherapy Response in Urologic Cancers.
    Pfail J, Drobner J, Doppalapudi K, Saraiya B, et al · · 2024 · cited 6× · PMID 38846356 · DOI 10.33696/cancerimmunol.6.078
  3. The Role of the Microbiome in Cancer Therapies: Current Evidence and Future Directions.
    Chalif J, Goldstein N, Mehra Y, Spakowicz D, et al · · 2025 · cited 5× · PMID 39856008 · DOI 10.1016/j.hoc.2024.12.005
  4. Role of Gut Microbiome in Cancer Treatment.
    Mishra V, Mishra Y. · · 2024 · cited 4× · PMID 39282183 · DOI 10.1007/s12088-024-01340-4
  5. Unveiling the Interplay Between the Human Microbiome and Gastric Cancer: A Review of the Complex Relationships and Therapeutic Avenues.
    Al-Matouq J, Al-Ghafli H, Alibrahim NN, Alsaffar N, et al · · 2025 · cited 1× · PMID 39858007 · DOI 10.3390/cancers17020226
  6. Operationalizing Team Science at the Academic Cancer Center Network to Unveil the Structure and Function of the Gut Microbiome.
    McDonnell KJ. · · 2025 · PMID 40142848 · DOI 10.3390/jcm14062040

Verify or expand the search:

Other trials of Biospecimen Collection

Trials testing the same drug.

Other recruiting trials for Stage I Prostate Cancer AJCC v7

Currently open trials in the same condition.

Other City of Hope Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04775355.

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