Prostate CancerNCT05840484
Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Active Surveillance
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 30 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
- 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.
- Patients must agree to comply with the surveillance schedule.
- Patients must be over 18 years of age
- Written informed consent
- Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.
Who cannot join
- Patients are ineligible if they choose not to share their medical data for research purposes.
- Prior radiation therapy for treatment of the primary tumor.
- Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Christopher Logothetis, MD, 713-563-7210, clogothe@mdanderson.org
Christopher Logothetis, MD
About this study
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..
Read the detailed description
Primary objectives:
- 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:
- Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities.
- Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction.
- 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
- Conditions
- Prostate Cancer
- Being tested
- Active Surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort-1 | Participants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance Receives: Other: Active Surveillance | |
| Cohort-2 | Participants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making); Receives: Other: Active Surveillance | |
| Cohort-3 | Participants with severe medical comorbidities (defined as CCI estimated 10-year survival < 50% and agreed by treating clinician) and high- or very high-risk group localized prostate cancer.
Clinical trial investigators and staff will make every effort to integrate study visits with the subjects' clinic visits during participation. Receives: Other: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start29 Mar 2023
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Logothetis, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840484
- Sponsor's protocol ID
- 2022-0297
- Other IDs
- NCI-2023-03146
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
- ClinicalTrials.gov ID
- NCT05840484
- Acronym / sponsor ID
- 2022-0297
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Detailed description
Primary objectives:
- 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:
- Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities.
- Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction.
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort-1 | – | Other: Active SurveillanceParticipants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance |
| Cohort-2 | – | Other: Active SurveillanceParticipants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making); |
| Cohort-3 | – | Other: Active SurveillanceParticipants with severe medical comorbidities (defined as CCI estimated 10-year survival < 50% and agreed by treating clinician) and high- or very high-risk group localized prostate cancer. Clinical trial investigators and staff will make every effort to integrate study visits with the subjects' clinic visits during participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (6 listed)
- Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
- 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.
- Patients must agree to comply with the surveillance schedule.
- Patients must be over 18 years of age
- Written informed consent
Key exclusion criteria (3 listed)
- Patients are ineligible if they choose not to share their medical data for research purposes.
- Prior radiation therapy for treatment of the primary tumor.
- Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active SurveillanceParticipants 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. | Other | Cohort-1, Cohort-2, Cohort-3 |
Primary outcome
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
Time frame: through study completion; an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Logothetis, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Logothetis, MD (713-563-7210, clogothe@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.