Bright White Light Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: ADT combination therapy

Must not be taking: Investigational agents

Disqualifiers: Brain metastases, Severe sleep disorders, Eye diseases, others

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how bright white light therapy can help patients with advanced prostate cancer reduce fatigue and depression. Low testosterone levels during treatment often cause these issues. Participants wear light therapy glasses to determine if they improve mood and energy levels. This trial suits men with advanced prostate cancer undergoing specific combination treatments who struggle with fatigue or mood changes. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, participants are allowed to continue with eligible treatments if they discontinue baseline hormonal treatment, unless they stop due to cancer progression.

What prior data suggests that bright white light therapy is safe for prostate cancer patients?

Research has shown that bright white light (BWL) therapy is generally easy to use and has few side effects. For cancer patients, such as those with prostate cancer undergoing antiandrogen therapy (ADT), BWL may help reduce fatigue and improve mood. It has been used for these purposes in other contexts with minimal issues.

One study suggested that BWL might enhance muscle strength and energy levels in older men. This finding is encouraging for those experiencing fatigue from cancer treatments. The low risk of side effects makes BWL a promising option for support during cancer therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about Bright White Light (BWL) Therapy for prostate cancer because it offers a non-invasive approach that differs significantly from traditional treatments like surgery, radiation, and hormone therapy. Unlike conventional therapies that directly target cancer cells or hormones, BWL Therapy uses light exposure through specialized glasses to potentially enhance the effectiveness of standard treatments. This innovative delivery method aims to improve patient outcomes with fewer side effects, making it an attractive option for enhancing quality of life during cancer treatment. By exploring how light therapy can complement existing therapies, researchers hope to unlock new ways to manage and treat prostate cancer.

What evidence suggests that bright white light therapy is effective for reducing fatigue and depression in prostate cancer patients?

Research has shown that bright white light (BWL) therapy can alleviate sleep and mood problems in cancer patients. Studies have found BWL effective in treating sleep issues, which are common during cancer treatment. It also improves mood and reduces feelings of depression. In this trial, participants will be divided into two groups: Group I will begin BWL therapy immediately, while Group II will start after a delay. For prostate cancer patients, BWL may help with fatigue and mood changes caused by treatments that lower testosterone. The therapy is safe, easy to use, and has few side effects, making it a promising option for improving quality of life. ^{1 2 3 4 6}

Who Is on the Research Team?

William Dale

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

Men over 60 with advanced prostate cancer, eligible for ADT combination therapy, and not currently on other investigational drugs. They should have a life expectancy of at least 18 months, no severe psychological impairments or night shift work, and no recent eye surgery or light sensitivity issues. Participants must be stable with controlled illnesses and without brain metastases or severe sleep disorders.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through lab tests.

My heart is healthy enough for this trial, meeting the NYHA class 2B or better.

Expected time to next treatment of >= 12 months and life expectancy of >= 18 months, as determined by a study Investigator

Exclusion Criteria

I have used light therapy for fatigue or depression.

My prostate cancer is rapidly worsening, and I may have less than 18 months to live.

I have recovered from side effects of previous cancer treatments, except for hair loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ADT combination therapy with immediate or delayed bright white light therapy

12 months

Regular visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bright White Light Therapy

Trial Overview The trial is testing if Bright White Light (BWL) Therapy can reduce fatigue and depression in men undergoing ADT combination therapy for advanced prostate cancer. It involves using bright white light to regulate sleep-wake cycles and potentially improve mood by increasing serotonin levels.

How Is the Trial Designed?

Group I: Group II (Delayed BWL therapy) Experimental Treatment 5 Interventions

Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial.

Group II: Group I (Immediate BWL therapy) Experimental Treatment 4 Interventions

Patients wear AYOpro BWL therapy glasses starting on day 1 of SOC ADT combination therapy for 12 months on trial.

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+

Published Research Related to This Trial

Photodynamic therapy (PDT) for localized prostate cancer uses light to activate a photosensitizing agent, generating free radicals that destroy cancerous tissue without spreading cancer to surrounding areas.

This treatment is safe for repeated use, even on previously irradiated tissues, and ongoing clinical trials suggest it could soon become a standard option for patients with organ-confined prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photodynamic therapy in localised prostate cancer]. Ramírez Backhaus, M., Trassierra Villa, M., Vera Donoso, CD., et al.[2019]

Photodynamic therapy (PDT) has evolved since its initial use for prostate cancer in 1990, now utilizing advanced techniques and photosensitizers that minimize side effects, making it a promising treatment option.

Current research is focused on establishing PDT's effectiveness as a primary or salvage treatment for organ-confined prostate cancer, highlighting its potential role in modern cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for prostate cancer--an emerging approach for organ-confined disease. Moore, CM., Emberton, M., Bown, SG.[2011]

Photodynamic therapy (PDT) using the photosensitizer pheophorbide a (PhA) effectively killed androgen-insensitive prostate cancer PC-3 cells, showing a dose-dependent response in both photosensitizer and light exposure.

The treatment triggered significant autophagy and reactive oxygen species (ROS) production, leading to cell cycle arrest and apoptosis, indicating a promising mechanism for targeting hormone-refractory prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy induced cell death of hormone insensitive prostate cancer PC-3 cells with autophagic characteristics. Xu, DD., Lam, HM., Hoeven, R., et al.[2016]

Photodynamic therapy is a promising new treatment for prostate cancer that uses a photosensitizing agent activated by laser light to induce tumor necrosis, with treatment effectiveness evaluated through MRI imaging.

MRI results at one week post-treatment show an increase in the treated lobe's volume and a large area of necrosis, while six-month follow-up MRI reveals significant changes in prostate shape and signal, establishing a new baseline for future monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-treatment MRI aspects of photodynamic therapy for prostate cancer. Kulik, M., Nedelcu, C., Martin, F., et al.[2022]

Photodynamic therapy (PDT) using the second-generation photosensitizer aluminum disulfonated phthalocyanine (AlS2Pc) showed promising results in treating localized prostate cancer in dogs, with macroscopic lesions up to 12 mm in diameter, indicating effective tumor targeting.

In contrast, the other photosensitizer, 5-aminolevulinic acid (ALA), produced much smaller lesions (1-2 mm) and was less effective, suggesting that AlS2Pc may be a more viable option for PDT in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interstitial photodynamic therapy in the canine prostate with disulfonated aluminum phthalocyanine and 5-aminolevulinic acid-induced protoporphyrin IX. Chang, SC., Buonaccorsi, GA., MacRobert, AJ., et al.[2019]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.6_suppl.75

The effects of bright white light therapy on obese frailty in ... BWL may offset negative effects of ADT for older men with prostate cancer, through improved muscle strength, maintained energy levels, and no waist ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425005901

Effectiveness and Safety of Bright Light Therapy in ... BLT is well-tolerated, easy to administer and has relatively low costs. BLT appears to be effective for sleep disturbances in oncological patients.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40185343/

Effectiveness and Safety of Bright Light Therapy in ... Light therapy has showed promising results, providing a safe and potentially effective treatment for a variety of psychological symptoms.

4. dana-farber.org dana-farber.org/clinical-trials/24-332

A Phase 2 Study of Bright White Light During Treatment ... This phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate cancer ...

5. nature.com nature.com/articles/s41392-025-02140-y

Phototherapy in cancer treatment: strategies and challenges Phototherapy has emerged as a promising modality in cancer treatment, garnering considerable attention for its minimal side effects, exceptional spatial ...

6. careacross.com careacross.com/clinical-trials/trial/NCT05869682

Bright White Light Therapy in Reducing Cancer-Related ... Summary: This phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate ...