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New treatment option for Advanced Prostate Carcinoma
Official title Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy
ClinicalTrials.gov ID: NCT05869682
What this study is testing
What is Combination Drug Therapy?
Combination Drug Therapy is an investigational medicine, being studied as a potential treatment for advanced prostate carcinoma.
Also referred to as Drug Therapy, Combination.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, men only
You may be able to join if
- Participants must have histologically or cytologically confirmed prostate cancer
- Participants must have radiographic evidence of measurable disease, defined as at least one lesion that can be accurately measured in at least one...
- Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer) plus abiraterone acetate and prednisone or darolutamide (triplet...
- Age \>= 60 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
You likely can't join if
- Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer as the expected median time to progression to next...
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the...
- Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide for participants planning to...
- Participants who are receiving any other investigational agents
- Participants with brain metastases are ineligible due to the limited life expectancy of men with prostate cancer metastases to brain
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed prostate cancer
- Participants must have radiographic evidence of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and...
- Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer) plus abiraterone acetate and prednisone or darolutamide (triplet therapy), or ADT plus enzalutamide, apalutamide, or darolutamide (doublet...
- Age \>= 60 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Expected time to next treatment of \>= 12 months and life expectancy of \>= 18 months, as determined by a study Investigator
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin =\< institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =\< 3 x institutional ULN
- Creatinine =\< institutional ULN OR
- Glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Ability to understand and the willingness to sign a written informed consent document
- Participants are still eligible and may proceed with the protocol and bright white light therapy if they discontinue baseline hormonal treatment, but plan to continue with another of the eligible treatments. However, if...
What rules you out
- Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer as the expected median time to progression to next therapy is \< 12 months
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
- Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide for participants planning to start treatment with abiraterone acetate, enzalutamide, apalutamide, or...
- Participants who are receiving any other investigational agents
- Participants with brain metastases are ineligible due to the limited life expectancy of men with prostate cancer metastases to brain
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study
- Histologic evidence of small cell prostate cancer
- Symptomatic skeletal event complication of prostate cancer such as cord compression, fracture, or need for radiation or surgery to a bone lesion within 6 months
- Uncontrolled pain related to prostate cancer or separate chronic condition
- Visceral crisis from prostate cancer suggesting rapidly progressive disease and life expectancy of \< 18 months
- Participants with uncontrolled intercurrent illness
- Concurrent second active malignancy
- Severe sleep disorders (e.g. Narcolepsy)
- Eye Diseases which limit the ability of light to be processed (e.g. untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or other retinal disorder)
- Severe psychological impairment (e.g., bipolar disorder or manic episodes)
- Current employment in night shift work
- Previous use of light therapy to alleviate fatigue or depressive symptoms
- Currently recovering from previous eye surgery within the past 6 months that causes eye irritation
- Sensitivity to light, epilepsy, or a history of seizures
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.