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Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

ConditionsProstate Cancer (Adenocarcinoma)Metastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males aged 18 years of age and above.

Prostate adenocarcinoma

Absolute PSA ≥ 2.0 ng/mL at screening.

PSA (+/- radiographic) progression after having been on abiraterone and prednisone for at least 12 weeks.

Disqualifiers

Active infection or other medical condition that would make dexamethasone use contraindicated

Any chronic medical condition requiring a higher systemic dose of corticosteroid

Pathological finding consistent with small cell carcinoma of the prostate

Has imminent or established spinal cord compression based on clinical findings and/or MRI.

Trial design

Design model

Single group

Treatments tested in this trial

  • Abiraterone acetate

    Drug

    Abiraterone acetate 1000mg/ day

  • Dexamethasone

    Drug

    Dexamethasone 0.5mg/day

  • Metronidazole

    Drug

    Metronidazole 1500mg/ per day

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Arm 1: Abiraterone + DexamethasoneExperimental treatment 2 interventions
Group B: Arm 2: Abiraterone + Dexamethasone + metronidazoleExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with PSA30 response

Number of participants with castration resistant prostate cancer who have a ≥ 30% decline in PSA from baseline until 24 weeks.

Time frame
24 weeks

Secondary outcomes

1

Number of participants with PSA50 response

Number of participants with castration resistant prostate cancer who have a ≥ 50% decline in PSA from baseline until 12 weeks.

Time frame
12 weeks
2

PSA Progression Free Survival

Number of participants with PSA progression according to PCWG3 (25% rise in PSA from nadir and increase of at least 2ng/mL)

Time frame
12 weeks
3

Number of participants with progression

progression is defined as: * Progression of soft tissue lesions according to RECIST 1.1 Criteria. * Progression of bone lesions detected with bone scan according to PCWG3 criteria. * Radiologically-confirmed spinal cord compression or pathological fracture due to malignant progression, or other clinical event deemed to be cancer-related, or death.

Time frame
24 weeks
4

Number of grade 3-5 toxicities

Toxicity is evaluated based on current CTCAE standard grading scales.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

United States Department of Defense

Collaborator

Prostate Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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