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 phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment with antiandrogen therapy (ADT) combination therapy. Combination treatment including ADT plus chemotherapy and androgen receptor (AR) targeted therapy or ADT plus AR targeted therapies work by reducing testosterone. Most prostate tumor cells rely on testosterone to help them grow; therefore, ADT combination therapy causes prostate tumor cells to die or to grow more slowly leading to improved overall survival in men with advanced prostate cancer when compared with ADT alone. However, lower levels of testosterone is also commonly associated with worsening fatigue and depression. If prolonged and severe, these complications can alter patient treatment plans, impacting not just quality of life, but leading to inadequate cancer control. BWL therapy is a type of phototherapy that utilizes bright white full-spectrum light, either through a light box or light therapy glasses to help regulate circadian rhythms. Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle, including the sleep-wake cycle which can become disrupted in cancer patients undergoing treatment, leading to increased fatigue. Additionally, exposure to bright light may increase the production of serotonin, a neurotransmitter that is associated with mood regulation. BWL therapy with AYOpro light therapy glasses may serve as a supportive care measure for men with advanced prostate to help reduce fatigue, as well as improve mood and overall quality of life during ADT combination therapy to maintain cancer care without suffering complications of therapy.

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.

How does bright white light therapy differ from other prostate cancer treatments?

Bright white light therapy, also known as photodynamic therapy (PDT), is unique because it uses light to activate a drug that targets cancer cells, minimizing damage to surrounding tissues. Unlike traditional treatments like surgery or radiation, PDT can be repeated multiple times without accumulating toxicity and is effective even in hormone-resistant prostate cancer. ^{1 2 3 4 5}

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) 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 (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 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]

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 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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapy induced cell death of hormone insensitive prostate cancer PC-3 cells with autophagic characteristics. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for prostate cancer--an emerging approach for organ-confined disease. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Interstitial photodynamic therapy in the canine prostate with disulfonated aluminum phthalocyanine and 5-aminolevulinic acid-induced protoporphyrin IX. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Photodynamic therapy in localised prostate cancer]. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Post-treatment MRI aspects of photodynamic therapy for prostate cancer. [2022]