Microbiome Changes for Prostate Cancer

Overseen By Tanya B Dorff

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must be taking: Androgen deprivation therapy

Disqualifiers: Inflammatory bowel disease, cystitis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the gut and urine microbiome (the community of bacteria, fungi, and viruses) changes in prostate cancer patients undergoing hormone and radiation treatments. Researchers seek to determine if these microbiome changes can affect healing, especially since radiation can sometimes cause discomfort or inflammation. By studying these changes, researchers hope to discover new ways to improve the quality of life for prostate cancer patients. Men with prostate cancer who plan to receive radiation therapy and can provide urine and stool samples at specific times may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how androgen deprivation therapy and radiation therapy impact the urinary and gut microbiome in prostate cancer patients. Unlike current treatments that focus on directly eliminating cancer cells, this study looks at how these therapies might alter the body's microbiome, potentially affecting overall health and treatment outcomes. By understanding these changes, researchers hope to improve future treatment strategies and patient care by considering the microbiome's role, which is a relatively new area of exploration in cancer therapy.

Who Is on the Research Team?

Tanya B Dorff

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Pathologically confirmed prostate cancer, with a plan to receive radiation therapy for either definitive (cohort A) or salvage (cohort B) therapy. Patients without planned androgen deprivation therapy (ADT) will be accrued to cohort C

Cohort A will be restricted to Gleason grade group 3 or higher (4+3 or 8-10) so that androgen deprivation will be indicated

Cohort B will not be restricted by Gleason grade but will require rising prostate-specific antigen (PSA) and a plan for ADT with salvage radiation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Androgen Deprivation Therapy

Participants undergo androgen deprivation therapy and collection of stool and urine samples

Duration not specified

Sample collection before and after therapy

Radiation Therapy

Participants receive radiation therapy and complete questionnaires

Duration not specified

Questionnaires before, mid-way, and after therapy

Follow-up

Participants are monitored for changes in microbiome and radiation toxicity

Up to 3 years

Every 6 months until 3 years from radiation completion

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection

How Is the Trial Designed?

Group I: Observational (biospecimen collection, questionnaire) Experimental Treatment 4 Interventions

Patients undergo collection of stool and urine samples within 2 weeks before hormone therapy or radiation therapy, after hormone therapy but before start of radiation therapy, and after completion of radiation therapy. Patients also complete a series of questionnaires prior to starting radiation therapy, mid-way through radiation therapy, and after completion of radiation therapy (within 1-3 weeks, at 3 months, and then every 6 months until 3 years from radiation completion). Patients' medical records are also reviewed.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+