What side effects are associated with this type of intervention?

Common treatments for prostate cancer include radiation therapy, surgery, and hormone therapy. Shorter course radiation therapy, which aims to reduce the duration and intensity of treatment, can lead to side effects such as fatigue, urinary symptoms (e.g., increased frequency, urgency, discomfort), bowel issues (e.g., diarrhea, rectal bleeding), and erectile dysfunction. Surgery, particularly prostatectomy, may result in urinary incontinence and sexual dysfunction. Hormone therapy can cause hot flashes, reduced libido, osteoporosis, and cardiovascular issues. Patients should discuss these potential side effects with their healthcare provider to make informed decisions about their treatment options.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, particularly for metastatic castration-resistant prostate cancer (mCRPC). Notable approvals include lutetium Lu 177 vipivotide tetraxetan, which has shown significant improvements in progression-free survival and overall survival in patients with PSMA-positive mCRPC. Additionally, radium-223 dichloride (Ra-223) has been approved for patients with symptomatic bone metastases, offering a targeted approach that can be combined with other therapies. These treatments, while not directly reducing the duration of radiation therapy, represent advancements in targeted and systemic therapies that can complement radiation strategies, potentially improving patient outcomes and adherence.

What other types of research exist?

Promising novel alternatives to shorter course radiation therapy for prostate cancer patients include: 1) Short-term androgen-targeted therapy (ATT), which has shown feasibility and patient tolerability with a sustained decrease in tumor volume over 18 months. 2) Androgen deprivation therapy (ADT) combined with abiraterone, which has been preferred for locally advanced nonmetastatic prostate cancer. 3) Bipolar androgen therapy (BAT), which has demonstrated potential in restoring sensitivity to other treatments in castration-resistant prostate cancer (CRPC). 4) Immunotherapy with agents like pembrolizumab for patients with specific genetic markers (dMMR or high TMB). These alternatives could potentially improve access and adherence to treatment by offering effective, shorter-term, and less intensive options.

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NAVAH for Cancer

N/A

Waitlist Available

Led By Shearwood McClelland III, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately following radiotherapy treatment

Awards & highlights

Study Summary

This trial found that African-Americans have less access to optimal cancer care, resulting in higher death rates & shorter survival times.

Who is the study for?

This trial is specifically for African-American adults over 18 with confirmed breast or prostate cancer. Participants must be able to give informed consent and understand the study requirements. It's not open to individuals who are not of African-American ethnicity or those without a confirmed diagnosis.Check my eligibility

What is being tested?

The NAVAH intervention is being tested to see if it can improve the completion rates of radiation therapy among African-American patients with breast or prostate cancer, addressing disparities in access to optimal cancer care.See study design

What are the potential side effects?

Since NAVAH is an intervention aimed at improving treatment adherence rather than a drug, traditional side effects are not applicable. However, there may be indirect effects related to changes in how radiation therapy is managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following radiotherapy treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following radiotherapy treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following radiotherapy treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of barriers to navigator access

Secondary outcome measures

Assess the impact of patient navigation on patient access to radiation oncology care

Minority financial toxicity differences

Trial Design

1Treatment groups

Experimental Treatment

Group I: Navigator-Assisted Hypofractionation (NAVAH)Experimental Treatment1 Intervention

This pilot cohort study is designed as follows: Navigator discussion with patients prior to the start of radiation therapy simulation (15-30 minutes). Navigator administration of survey with patients after completion of radiation therapy simulation but before the start of radiation therapy (30-45 minutes) Navigator administration of post-treatment survey and financial toxicity survey instrument after the completion of radiation therapy (60 minutes).

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include radiation therapy and androgen deprivation therapy (ADT). Radiation therapy destroys cancer cells by damaging their DNA, preventing them from growing and dividing. ADT reduces levels of male hormones that can promote cancer growth, either through medication or surgery. Shorter course radiation therapy is particularly important as it aims to reduce the duration and intensity of treatment, improving patient access, adherence, and quality of life by minimizing side effects and treatment burden.

Overview of international collaborative group prostate cancer trials.

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterOTHER

318 Previous Clinical Trials

339,877 Total Patients Enrolled

3 Trials studying Prostate Cancer

520 Patients Enrolled for Prostate Cancer

Gilead SciencesIndustry Sponsor

1,085 Previous Clinical Trials

847,945 Total Patients Enrolled

1 Trials studying Prostate Cancer

31 Patients Enrolled for Prostate Cancer

Case Comprehensive Cancer CenterLead Sponsor

455 Previous Clinical Trials

31,629 Total Patients Enrolled

31 Trials studying Prostate Cancer

2,913 Patients Enrolled for Prostate Cancer

Media Library

$Navigator-Assisted Hypofractionation (NAVAH) Clinical Trial Eligibility Overview. Trial Name: NCT05978232 — N/A$

$Prostate Cancer Research Study Groups: Navigator-Assisted Hypofractionation (NAVAH)$

$Prostate Cancer Clinical Trial 2023: Navigator-Assisted Hypofractionation (NAVAH) Highlights & Side Effects. Trial Name: NCT05978232 — N/A$

$Navigator-Assisted Hypofractionation (NAVAH) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05978232 — N/A$

~133 spots leftby Jul 2027

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