MBM-02 (Tempol) for the Treatment of Biochemical Recurrent Prostate Cancer

Status unconfirmed · Phase 2

Conditions studied: Prostate Cancer Recurrent, Biochemical Recurrent Prostate Cancer

In brief

This is an open label trial to assess the efficacy of MBM-02 (Tempol) as a treatment for patients diagnosed with prostate cancer in biochemical recurrence.

Key facts

Study ID

NCT04876755

Run by

Matrix Biomed, Inc.

People needed

55

Starts

2021-05-30

Expected to finish

2023-02-01

Last updated by the study team

2021-05-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male 18 years or older;
• Histologically or cytologically confirmed diagnosis of prostate cancer;
• Patient must have had previous treatment with definitive surgery or radiation therapy, cryoablation, or brachytherapy;
• Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure. Prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
• Patient must have evidence of biochemical failure after primary therapy and subsequent progression. Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy:
• For radical prostatectomy the threshold for this study is PSA ≥ 0.8ng/mL
• For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 RTOG-ASTRO Consensus definition).
• PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached;
• PSA doubling time ≤ 12 months. PSA calculation requires two consecutive PSA rises (PSA2 and PSA3) above the threshold PSA (total 3 PSA values); PSA2 and PSA3 must be obtained within 12 months of study entry. All baseline PSAs should be obtained at the same reference lab.
• ECOG performance status less than or equal to 2;
• Ability to swallow the study drugs;
• If a male with a female partner of child bearing potential, adequate methods of contraception must be employed;
• If male, no sperm donation for 90 days until after the conclusion of the study;
• Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
• Be able to participate for the full term of the clinical investigation;
• Have a Karnofsky performance status of >70;
• Have a life expectancy ≥ 6 months; and
• Have adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
• Hematology:
• Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood
• Hepatic:
• Total bilirubin ≤ 2 x ULN Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5 x ULN
• Renal:
• creatinine clearance (CrCl) ≥ 60 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CrCl female = 0.85 x (CrCl male)

You may not qualify if…

• Evidence of metastatic disease on imaging studies (CT and/or bone scan);
• Diagnosis of diabetes mellitus defined as:
• Fasting blood glucose > 126 mg/dl or,
• Random blood glucose > 200 mg/dl
• Hemoglobin A1C > 6.5%
• Patients with QTc >480 msec
• Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy);
• Treatment within the last 30 days with any investigational drug;
• Radiation therapy within prior 6 months (prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed);
• Patient with previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions: Basal cell or squamous cell carcinoma of the skin or prior malignancy that has been adequately treated and patient has been continuously disease free for ≥ 2 years;
• Evidence of a significant medical illness, or a psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study;
• Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of the study drug;
• Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
• Have used an investigational drug within 28 days of the initiation of study treatment;
• Have a history of a positive blood test for HIV;
• At the time of screening, have a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study; and
• Body weight less than 35 kg (77 lbs.)

Where it is running

• Prostate Oncology Specialists — Marina del Rey, California, United States

Full record on ClinicalTrials.gov

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