Adjuvant Curcumin for Prostate Cancer

Overseen By Jessica Williams

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Antiplatelets, Anticoagulants, Curcumin

Disqualifiers: Gallbladder issues, Ulcers, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

608 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether curcumin, a compound in turmeric, can prevent prostate cancer from returning after surgery. Participants will take either curcumin or a placebo to determine if curcumin helps patients remain cancer-free longer. The trial seeks men who have undergone prostate surgery, show no signs of cancer spread, and do not plan to have hormone or radiation therapy. Those who meet these criteria may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking cancer prevention research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take curcumin during the study. If you are on antiplatelet or anticoagulant medications, you may need to stop them, except for low-dose aspirin (81mg), which is allowed with close monitoring.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that curcumin is generally safe for people. Studies have found that even with long-term use, individuals tolerate curcumin well. One study found no major side effects, deeming it safe during use. Another study noted that curcumin was well tolerated when combined with other cancer treatments.

Overall, this evidence suggests that curcumin is unlikely to cause harm, making it a potentially safe choice for those interested in joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Curcumin is unique because it's derived from turmeric, a natural spice known for its anti-inflammatory properties. Unlike traditional treatments for prostate cancer, which often involve hormone therapy, surgery, or radiation, curcumin offers a potential alternative by targeting inflammation, which is a key player in cancer progression. Researchers are excited about curcumin because it could provide a gentler option with fewer side effects, offering hope for improving quality of life for patients.

What evidence suggests that Curcumin might be an effective treatment for prostate cancer?

Research has shown that curcumin, which participants in this trial may receive, might help treat prostate cancer by affecting cancer cell growth. Studies have found that curcumin can stop cancer cells from multiplying and even induce their death. Specifically, curcumin can lower the activity of a protein called AR, which aids cancer cell growth, and reduce PSA levels, a marker for prostate cancer. It also blocks the pathways tumors use to grow and spread. Overall, curcumin shows promise in slowing or stopping the progression of prostate cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

Men aged 30-80 with prostate cancer who've had surgery to remove the prostate, no lymph node or metastatic disease, and a life expectancy of at least 3 years. They should not have severe liver, kidney, or bone marrow problems and must not be planning additional hormone or radiation therapy post-surgery.

Inclusion Criteria

Undetectable PSA at enrollment

Life expectancy of 3 years

I had surgery to remove my prostate due to cancer.

Exclusion Criteria

AST/ALT ≥ 2 times upper limit of normal

It has been over 3 months since my last surgery.

I still have visible cancer after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Curcumin 500 mg orally twice a day or placebo

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin
• placebo

Trial Overview The study is testing if Curcumin can prevent cancer from coming back in patients who've undergone surgery for prostate cancer. Participants will either receive Curcumin or a placebo to see which one helps more in stopping the cancer's return.

How Is the Trial Designed?

Group I: Curcumin Active Control 2 Interventions

Curcumin 500 mg orally twice a day

Group II: sugar pill Placebo Group 2 Interventions

placebo orally twice a day

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Yair Lotan

Lead Sponsor

Trials

1

Recruited

610+

yair lotan

Lead Sponsor

Trials

1

Recruited

610+

Published Research Related to This Trial

A significant number of prostate cancer patients (25%-50%) use complementary and alternative medicine (CAM) modalities, primarily vitamins and herbal preparations, despite limited evidence supporting their effectiveness against cancer.

The review concludes that there is insufficient evidence to recommend CAM therapies for prostate cancer treatment outside of clinical trials, highlighting the need for more rigorous evaluation and education for both oncologists and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicines in prostate cancer: from bench to bedside? Klempner, SJ., Bubley, G.[2021]

Five out of six curcumin analogues (A(2)-A(6)) were found to be more effective than curcumin itself in inhibiting the growth of PC-3 human prostate cancer cells, suggesting enhanced therapeutic potential.

These analogues also significantly increased apoptosis (cell death) in PC-3 cells and more effectively inhibited NF-κB activity, indicating a possible mechanism for their improved efficacy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cyclohexanone analogues of curcumin on growth, apoptosis and NF-κB activity in PC-3 human prostate cancer cells. Wei, X., DU, ZY., Cui, XX., et al.[2022]

Prostate cancer is a significant health issue, particularly in the United States and among Black men, with risk factors including age, genetics, and lifestyle choices, highlighting the need for better treatment options.

Curcumin, a compound found in turmeric, shows promise as a therapeutic agent against prostate cancer, with potential mechanisms of action that could inhibit cancer signaling pathways, suggesting it may serve as a chemopreventive agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular mechanisms of curcumin and its semisynthetic analogues in prostate cancer prevention and treatment. Jordan, BC., Mock, CD., Thilagavathi, R., et al.[2018]

Quercetin-decorated liposomes containing curcumin showed improved effectiveness in increasing the lifespan and body weight of mice with Dalton's ascites lymphoma compared to liposomes without quercetin, indicating enhanced therapeutic potential.

The study demonstrated that these liposomes, with a particle size of approximately 261.8 nm, not only improved the cytotoxicity against cancer cells (HT-29 and HCT-15) but also addressed curcumin's limitations like poor solubility and short biological half-life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. Ravichandiran, V., Masilamani, K., Senthilnathan, B., et al.[2018]

Curcumin, a compound found in turmeric, effectively inhibits the epidermal growth factor receptor (EGF-R) signaling in prostate cancer cells, which could help prevent cancer progression.

The study demonstrated that curcumin reduces EGF-R protein levels, inhibits its tyrosine kinase activity, and blocks its activation by ligands, suggesting it may be a promising preventive therapy for both androgen-dependent and androgen-independent prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of curcumin in human prostate cancer. II. Curcumin inhibits tyrosine kinase activity of epidermal growth factor receptor and depletes the protein. Dorai, T., Gehani, N., Katz, A.[2022]

The combination of curcumin and dutasteride significantly suppressed the proliferation of LNCaP prostate cancer cells and induced apoptosis, suggesting a potential therapeutic strategy for prostate cancer treatment.

This combination treatment also reduced levels of testosterone and dihydrotestosterone in the cancer cells, indicating it may effectively interfere with androgen activity within tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Curcumin Combined With the 5-alpha Reductase Inhibitor Dutasteride on LNCaP Prostate Cancer Cells. Nakayama, A., Ide, H., Lu, Y., et al.[2021]

Curcumin shows promise as a treatment for castration-resistant prostate cancer due to its ability to target multiple pathways, although its low bioavailability limits its effectiveness as a drug.

Research has led to the development of curcumin-based compounds that enhance its anticancer potential and improve pharmacokinetics, making them more suitable for clinical use in prostate cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin-based anti-prostate cancer agents. Chen, QH.[2019]

Curcumin, a compound found in turmeric, significantly enhances the effectiveness of TRAIL in inducing cell death in androgen-sensitive prostate cancer cells (LNCaP), suggesting a potential combination therapy for improved treatment outcomes.

The combination of curcumin and TRAIL activates both the extrinsic and intrinsic pathways of apoptosis, leading to increased cancer cell death, which highlights curcumin's role in sensitizing prostate cancer cells for TRAIL-mediated immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin (diferuloyl-methane) enhances tumor necrosis factor-related apoptosis-inducing ligand-induced apoptosis in LNCaP prostate cancer cells. Deeb, D., Xu, YX., Jiang, H., et al.[2020]

The review highlights the potential of combining dietary natural products like curcumin, quercetin, soybean isoflavones, silibinin, and EGCG to create synergistic effects that may enhance treatment outcomes for prostate cancer.

These findings suggest that future research could focus on designing hybrid agents that leverage these natural compounds for more effective prostate cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic Effects of Dietary Natural Products as Anti-Prostate Cancer Agents. Vue, B., Zhang, S., Chen, QH.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7696488/

Curcumin against Prostate Cancer: Current Evidence - PMC LNCaP and PC-3 prostate cancer cells were found to have constitutively activated Akt, and treatment with curcumin completely abolished Akt activation [59].

2. sciencedirect.com sciencedirect.com/science/article/pii/S2287888225000911

Therapeutic Potentials of Curcumin in Prostate Cancer After receiving 500 mg/kg curcumin three times weekly for 4 weeks, AR activity was inhibited, PSA expression was reduced, and tumor growth was ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03769766

Study Details | NCT03769766 | Trial of Curcumin to ... This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-15152-2

Curcumin in prostate cancer: a systematic review of molecular ... Therapeutic outcomes included apoptosis, necroptosis, cell cycle arrest, and suppression of migration and angiogenesis. Nanoformulations (e.g., ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1379389/full

Application and potential value of curcumin in prostate ... Curcumin exhibited inhibitory properties towards prostate tumor growth and demonstrated a beneficial effect on prostate cancer treatment.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30671976/

A randomized, double-blind, placebo-controlled trial to ... However, PSA elevation was suppressed with curcumin intake during the curcumin administration period. Curcumin at this dose was well tolerated and safe.

7. journals.lww.com journals.lww.com/ebp/fulltext/2023/08000/does_dietary_supplementation_with_the_turmeric.8.aspx

Does dietary supplementation with the turmeric derivative... Curcumin does not affect clinically significant treatment outcomes or quality of life in patients with localized prostate cancer.

8. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/turmeric

Turmeric Furthermore, curcumin may serve as a useful adjunct to cancer treatments: When combined with docetaxel and gemcitabine, it was found to be safe ...