What side effects are associated with this type of intervention?

Common treatments for prostate cancer include radical prostatectomy, external beam radiation therapy (RT), and brachytherapy. Radical prostatectomy often results in urinary incontinence and sexual dysfunction, with some recovery over time but persistent issues in many patients. RT can cause bowel symptoms such as urgency and frequency, which may persist, and sexual dysfunction, which tends to stabilize after initial decline. Brachytherapy shares similar side effects with RT. For older adults, comprehensive geriatric assessment and remote symptom monitoring can help manage these side effects by providing tailored care and timely interventions.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that align with comprehensive geriatric assessment and remote symptom monitoring. Key drugs include abiraterone and enzalutamide, which are used for metastatic castration-resistant prostate cancer and have shown efficacy in older adults. These drugs help manage symptoms and improve quality of life. Additionally, docetaxel, a chemotherapy agent, is approved for use in advanced prostate cancer, though its use in older adults requires careful assessment due to potential side effects. Remote symptom monitoring can be integrated with these treatments to track patient responses and manage side effects effectively.

What other types of research exist?

Promising novel alternatives for prostate cancer patients include focal therapy and low-intensity medical therapy. Focal therapy targets only the cancerous part of the prostate, minimizing side effects and preserving quality of life. Low-intensity medical therapy involves less aggressive treatment options that can be tailored to the patient's specific condition and overall health, potentially offering a better balance between treatment efficacy and quality of life.

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Supportive Care Intervention for Prostate Cancer (TOPCOP3 Trial)

N/A

Recruiting

Led By Shabbir Alibhai, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial focuses on frequent health assessments and monitoring for older men with prostate cancer to identify and manage health issues early, aiming to improve patient outcomes.

Who is the study for?

This trial is for men aged 70 or older with metastatic prostate cancer who are starting ARAT treatment. They must be able to give written consent and have a working phone. It's not for those who can't speak English, have a life expectancy under 3 months, or major neuropsychiatric issues like severe depression or dementia.

What is being tested?

The TOPCOP3 study tests the effectiveness of geriatric assessment and management (GA+M), remote symptom monitoring (RSM), both interventions together (GA+RSM), or neither. This pilot RCT aims to gather data on these supportive care methods to plan larger trials.

What are the potential side effects?

Since this trial focuses on supportive care rather than direct medical treatments, side effects may include discomfort from assessments, potential stress from frequent monitoring, and possible privacy concerns with remote communication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Health related quality of life in patients with metastatic prostate cancer

Number of participants with Grade 3-5 Toxicity

Secondary study objectives

Anorexia

Depression

Fatigue

+6 more

Other study objectives

Process evaluation: Acceptability

Process evaluation: Feasibility

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: RSM InterventionActive Control1 Intervention

RSM Intervention All participants in the RSM intervention arm will receive once-weekly symptom monitoring via email-based surveys using the 9-item Edmonton Symptom Assessment Scale within a secure customized REDCap interface. If patients prefer, weekly telephone calls will be done instead by a research assistant to elicit If there are moderate or severe symptoms (score of 4+ out of 10), an oncology nurse will obtain more detailed symptom information and provide evidence-based symptom-targeted recommendations using the pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) Practice Guide. Symptom monitoring will continue for 6 months or discontinuation of treatment.

Group II: GA+M InterventionActive Control1 Intervention

GA+M intervention arm All participants in the GA+M intervention arm will undergo a standardized GA by a trained nurse and geriatrician. The GA will include 8 domains (comorbidity, medication review, function, falls risk, nutrition, social supports, cognition, and mood) similar to our 5C protocol. Based on any detected abnormalities or issues, a standardized set of strategies will be implemented (e.g. increased falls risk will lead to detailed assessment of balance and gait, consideration of gait aid, and referral to outpatient physiotherapy). This follows the standard approach to implementing GA similar to recent trials in geriatric oncology including 5C. Telephone follow-ups at 1, 3 and 6 months by the nurse and review with the geriatrician as needed will be done to ensure identified issues have been addressed.

Group III: GA+RSM interventionActive Control1 Intervention

GA+RSM Combination Participants will receive both strategies as detailed above, with a GA at baseline.

Group IV: ControlActive Control1 Intervention

Control Usual care consists of brief verbal education and a drug pamphlet to all patients when starting an ARAT. There is no GA+M and no RSM at either site. Patients have access to a 24x7 oncology nursing line or a 24/7 pharmacy line.

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

Common treatments for prostate cancer include hormonal therapies, chemotherapy, and supportive care interventions. Hormonal therapies, such as androgen deprivation therapy (ADT), work by reducing or blocking the production of testosterone, which fuels prostate cancer growth. Chemotherapy, like docetaxel, targets rapidly dividing cancer cells, disrupting their growth and division. Supportive care interventions, including geriatric assessment and management, provide a comprehensive evaluation and tailored care for older adults, addressing comorbidities and overall health. Remote symptom monitoring uses technology to track and manage symptoms, ensuring timely interventions and improving quality of life. These treatments are crucial as they not only target cancer but also enhance the overall well-being and management of prostate cancer patients, particularly older adults.

Interventions for prostate cancer survivorship: A systematic review of reviews.Quality of life three years after diagnosis of localised prostate cancer: population based cohort study.Evaluating men with benign prostatic hyperplasia.