Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance

Prostate Cancer Clinical Trial

Official title:

Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840484
• Other study ID #: 2022-0297
• Secondary ID: NCI-2023-03146
• Status: Recruiting
• Start date: March 29, 2023
• Est. completion date: July 30, 2029

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Christopher Logothetis, MD
• Phone: 713-563-7210
• Email: clogothe[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prostate cancer is the most commonly diagnosed cancer in men. However, there is a wide range in prognosis determined by a host of factors. This study will evaluate the feasibility of guiding therapeutic intervention electronically facilitated symptom and disease monitoring in patients being followed on Active Surveillance. Additionally, we will develop a tissue and data resource to support discovery and hypothesis generation to evaluate germline and/or somatic alterations in relation to cancer-specific and overall outcomes..

Description:

Primary objectives:

1. Monitor cancer-specific outcomes of men who meet consensus criteria for active surveillance under one of three categories: 1) low or very low-risk prostate cancer, 2) intermediate risk with patient consent, or 3) severe medical comorbidities and high-risk localized prostate cancer or patient desire, despite recommendation

Secondary objectives:

1. Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities.

2. Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction.

3. Develop a tissue and data resource to support discovery and hypothesis generation focused on germline alterations, somatic alterations, and/or the interaction between the two in determining cancer-specific and overall outcomes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2029
• Est. primary completion date: July 30, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.

2. Patient must meet at least one of the following clinical indications for AS: National Comprehensive Cancer Network (NCCN) very low risk or low risk prostate cancer meeting consensus guidelines for AS; NCCN intermediate-risk prostate cancer requesting AS (per patient and clinician shared decision making); or have severe medical comorbidities (defined as CCI estimated 10-year survival < 50% and agreed by treating clinician) with high- or very high-risk localized prostate cancer.

3. Patients must agree to comply with the surveillance schedule.

4. Patients must be over 18 years of age

5. Written informed consent

6. Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.

Exclusion criteria:

1. Patients are ineligible if they choose not to share their medical data for research purposes.

2. Prior radiation therapy for treatment of the primary tumor.

3. Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Active Surveillance
Participants will be asked to complete questionnaires, have physical and rectal examinations, have prostate biopsies, and have imaging scans (such as MRIs). These visits will be done between every 6 months and every 2-3 years, depending on the test/procedure.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the 5-year disease progression rate of patients with low or very low-risk prostate cancer who choose to undergo active surveillance with remote monitoring		through study completion; an average of 1 year.

External Links

•   M D Anderson Cancer Center