~82 spots leftby Feb 2027

Supportive Care Intervention for Prostate Cancer

(TOPCOP3 Trial)

Recruiting in Palo Alto (17 mi)
+1 other location
SA
Overseen byShabbir M Alibhai, MD MSc
Age: 65+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Must be taking: ARATs
Disqualifiers: Severe depression, Dementia, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be starting or have recently started a specific type of prostate cancer medication (ARAT).

What data supports the effectiveness of the drug Lynparza (olaparib) for prostate cancer?

A phase II trial found that combining the antiandrogen abiraterone with the PARP inhibitor olaparib (Lynparza) significantly improved progression-free survival in patients with metastatic castration-resistant prostate cancer.12345

Is the GA+M Intervention (Olaparib and Radium-223) safe for humans?

The combination of Olaparib and Radium-223 has been studied for safety in men with prostate cancer that has spread to the bones. Common side effects included fatigue and anemia (low red blood cell count), but it was generally considered safe at the tested doses.46789

How is the GA+M, GA+RSM, and RSM drug different from other prostate cancer drugs?

The GA+M, GA+RSM, and RSM drug, known as Lynparza (also called AZD-2281, MK-7339, KU0059436), is unique because it is a PARP inhibitor, which works by blocking an enzyme used by cancer cells to repair their DNA, leading to cell death. This mechanism is different from traditional treatments like chemotherapy or hormone therapy, which target cancer cells in other ways.1011121314

Research Team

SA

Shabbir M Alibhai, MD MSc

Principal Investigator

UHN - Princess Margaret Cancer Centre

Eligibility Criteria

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.

Inclusion Criteria

I am 70 years old or older.
Able to provide written informed consent
Has a working telephone
See 1 more

Exclusion Criteria

I do not have severe depression or moderate to severe dementia.
Unable to speak English (as contact with the nurse interventionist is via phone, not all outcome measures are available in multiple languages)
Life expectancy less than 3 months as estimated by the oncologist

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GA+M, RSM, both interventions, or control for 6 months

6 months
Weekly symptom monitoring and follow-ups at 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • GA+M Intervention (Behavioural Intervention)
  • GA+RSM intervention (Behavioural Intervention)
  • RSM intervention (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+
Dr. Brad Wouters profile image

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith profile image

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Findings from Research

In a study of 5,588 men with metastatic castration-resistant prostate cancer (mCRPC) in Ontario, both androgen-receptor-axis-targeted therapies (ARATs) and taxanes showed similar survival rates across first, second, and third lines of treatment, suggesting comparable efficacy.
Survival times for patients treated with ARATs were 13.0 months for first-line, 11.5 months for second-line, and 8.9 months for third-line therapy, while taxane treatments had survival times of 16.7 months for first-line, 11.3 months for second-line, and 7.8 months for third-line, indicating that both treatment types can be effective options in managing mCRPC.
A real-world retrospective analysis of the management of metastatic castrate-resistant prostate cancer in Ontario, Canada from 2010 - 2018.Moldaver, DM., Hassan, S., Seung, SJ., et al.[2023]
A phase II trial indicates that the combination of the antiandrogen abiraterone and the PARP inhibitor olaparib significantly enhances progression-free survival in patients with metastatic castration-resistant prostate cancer.
This benefit occurs regardless of the patients' homologous recombination repair-mutation status, suggesting a broad applicability of this treatment strategy.
Abiraterone-Olaparib Combo Aids Men with mCRPC.[2019]
In the PREVAIL study involving 872 men with metastatic castration-resistant prostate cancer, significant declines in prostate-specific antigen (PSA) levels after 3 months of enzalutamide treatment were linked to improved overall survival and progression-free survival outcomes.
Specifically, 88% of patients experienced a PSA decline of at least 30%, and greater declines were associated with longer survival and better quality of life, indicating that monitoring PSA levels can provide valuable prognostic information for treatment effectiveness.
Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial.Armstrong, AJ., Lin, P., Higano, CS., et al.[2021]

References

A real-world retrospective analysis of the management of metastatic castrate-resistant prostate cancer in Ontario, Canada from 2010 - 2018. [2023]
Abiraterone-Olaparib Combo Aids Men with mCRPC. [2019]
Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial. [2021]
Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: An Open-label Phase 1 Study. [2018]
Survival outcomes and prognostic factors for first-line abiraterone acetate or enzalutamide in patients with metastatic castration-resistant prostate cancer. [2023]
Efficacy and safety outcomes of darolutamide in patients with non-metastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomised phase 3 ARAMIS trial. [2023]
Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial. [2022]
A Phase I Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases (COMRADE). [2023]
Therapy Update for Metastatic Castration-Resistant Prostate Cancer. [2017]
Intensification of Systemic Therapy in Addition to Definitive Local Treatment in Nonmetastatic Unfavourable Prostate Cancer: A Systematic Review and Meta-analysis. [2022]
Poly(adenosine diphosphate-ribose) polymerase inhibitor combinations in first-line metastatic castrate-resistant prostate cancer setting: a systematic review and meta-analysis. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial. [2019]
Safety and effectiveness of enzalutamide in men with metastatic, castration-resistant prostate cancer. [2021]
Phase II trial assessing granulocyte-macrophage-colony stimulating factor, ketoconazole plus mitoxantrone in metastatic castration-resistant prostate cancer progressing after docetaxel treatments. [2018]