76 Participants Needed

COAST Therapy for Prostate Cancer

(COAST Trial)

AB
JB
Overseen ByJasmin Brooks
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The purpose of this Phase I/II study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of solid tumor cancers. The drugs are hydroxychloroquine, metformin, sirolimus, dasatinib and nelfinavir and are given orally.

Will I have to stop taking my current medications?

The trial requires that patients stop using statins (cholesterol-lowering drugs) within 48 hours before starting the study treatment if they are taking nelfinavir mesylate. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the COAST Therapy drugs for prostate cancer?

Research suggests that metformin, one of the drugs in the COAST Therapy, may improve survival in prostate cancer patients and has potential anticancer effects. It is also being tested in combination with standard treatments for high-risk prostate cancer.12345

Is Metformin safe for use in humans?

Metformin is considered a safe and well-tolerated treatment, commonly used for type 2 diabetes and being explored for prostate cancer treatment.23467

What makes the COAST Therapy drug unique for prostate cancer?

The COAST Therapy drug is unique because it combines multiple agents like Hydroxychloroquine, Metformin, Sirolimus, Dasatinib, and Nelfinavir, which are not typically used together for prostate cancer. This combination targets different pathways in cancer cells, potentially offering a novel approach compared to standard treatments like docetaxel-based therapies.89101112

Eligibility Criteria

Adults with advanced solid tumors or prostate cancer, who have tried standard treatments without success. They must be relatively healthy, with stable vital signs and organ function, not on certain blood thinners or statins, and willing to use contraception if they can have children.

Inclusion Criteria

Platelet count ≥ 75,000 cells / mm3
I can take care of myself and am up and about more than half of the day.
Serum creatinine ≤ 1.5 times ULN
See 15 more

Exclusion Criteria

I haven't had radiation, surgery, or experimental treatments in the last 28 days.
I am currently taking blood thinners like coumadin or apixaban.
I have a serious health condition that might affect the study's goals.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I

Phase I cohort receives increasing components of the COAST regimen following a traditional 3+3 escalation design to determine the maximum tolerated dose.

Minimum of 3 months
Regular visits for dose escalation and monitoring

Treatment Phase II

Phase II evaluates the anti-tumor activity of the COAST RP2D combination in patients with advanced prostate cancer.

16 weeks
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PSA progression-free rate.

4 weeks

Treatment Details

Interventions

  • Hydroxychloroquine, Metformin, Sirolimus
  • Hydroxychloroquine, Metformin, Sirolimus, Dasatanib
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib
Trial OverviewThe trial is testing a combination of five drugs: hydroxychloroquine, nelfinavir, metformin, dasatinib, and sirolimus for their safety and effectiveness in treating solid tumor cancers including advanced prostate cancer.
Participant Groups
6Treatment groups
Experimental Treatment
Group I: Dose level 4Experimental Treatment1 Intervention
Group II: Dose level 3bExperimental Treatment1 Intervention
Group III: Dose level 3aExperimental Treatment1 Intervention
Group IV: Dose level 2bExperimental Treatment1 Intervention
Group V: Dose level 2aExperimental Treatment1 Intervention
Group VI: Dose level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Findings from Research

In a study of 551 patients diagnosed with high-grade prostatic intraepithelial neoplasia (HGPIN), metformin use in diabetic patients was linked to a significantly lower risk of developing prostate cancer compared to those who did not use metformin.
Longer durations of metformin treatment (≥2 years) were associated with a reduced incidence of prostate cancer and lower Gleason scores, suggesting that metformin may have protective effects in diabetic patients with HGPIN.
The impact of metformin use on the risk of prostate cancer after prostate biopsy in patients with high grade intraepithelial neoplasia.Dell'Atti, L., Galosi, AB.[2018]
Metformin is a safe and well-tolerated medication that can be used alongside standard treatments for prostate cancer, potentially reducing side effects from castration.
The STAMPEDE trial, starting in summer 2016, will evaluate the effectiveness of metformin as a repurposed treatment for men with high-risk prostate cancer, aiming to confirm its additional anticancer benefits.
Repurposing Metformin as Therapy for Prostate Cancer within the STAMPEDE Trial Platform.Gillessen, S., Gilson, C., James, N., et al.[2021]
In a study of 25,695 male patients with type 2 diabetes, metformin users had a 20% lower risk of developing new-onset prostate cancer compared to those using sulfonylureas, indicating a potential protective effect of metformin.
Metformin was also associated with a 11% reduction in all-cause mortality compared to sulfonylurea users, suggesting that it may offer additional health benefits beyond blood sugar control.
Risk of New-Onset Prostate Cancer for Metformin Versus Sulfonylurea Use in Type 2 Diabetes Mellitus: A Propensity Score-Matched Study.Lee, YHA., Zhou, J., Hui, JMH., et al.[2022]

References

The impact of metformin use on the risk of prostate cancer after prostate biopsy in patients with high grade intraepithelial neoplasia. [2018]
Repurposing Metformin as Therapy for Prostate Cancer within the STAMPEDE Trial Platform. [2021]
Risk of New-Onset Prostate Cancer for Metformin Versus Sulfonylurea Use in Type 2 Diabetes Mellitus: A Propensity Score-Matched Study. [2022]
A novel biguanide derivative, IM176, induces prostate cancer cell death by modulating the AMPK-mTOR and androgen receptor signaling pathways. [2023]
Prostate Cancer-specific Survival After Radical Prostatectomy Is Improved Among Metformin Users but Not Among Other Antidiabetic Drug Users. [2022]
STAT3/LKB1 controls metastatic prostate cancer by regulating mTORC1/CREB pathway. [2023]
Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). [2021]
A phase I trial of docetaxel/estramustine/imatinib in patients with hormone-refractory prostate cancer. [2018]
A phase II trial of dexamethasone, vitamin D, and carboplatin in patients with hormone-refractory prostate cancer. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Metformin Has Positive Therapeutic Effects in Colon Cancer and Lung Cancer. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
The current role of chemotherapy in metastatic hormone-refractory prostate cancer. [2022]
Docetaxel and zoledronic acid in patients with metastatic hormone-refractory prostate cancer. [2018]