Biochemically Recurrent Prostate CarcinomaPhase 2NCT07073794
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
A Phase 2 study testing Cancer Therapeutic Procedure, Health Care Delivery and Questionnaire Administration in people with Biochemically Recurrent Prostate Carcinoma and Locally Advanced Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Biochemically Recurrent Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Metastatic Prostate Carcinoma
- What is being tested?
- Cancer Therapeutic Procedure, Health Care Delivery and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2026to 29 Sep 2028
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥ 18 years
- Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines
- Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse [co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted]
- Androgen deprivation therapy (ADT):
- Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length
- Degarelix SQ, 4 weeks cycle length
Show all 18Show fewer
- Chemotherapy: Cabazitaxel IV, 3 weeks cycle length
- Immunotherapy: Pembrolizumab IV, 3 weeks cycle length
- Bone modifying agent + any of the prostate cancer treatments:
- Zoledronic acid IV, 4 or 12 weeks cycle length
- Denosumab SQ, 4 or 12 weeks cycle length
- Patients who are anticipated to continue the treatment regimen they are currently prescribed for at least 18 weeks following registration (if on chemotherapy or immunotherapy) or 24 weeks following registration (for all other treatment regimens)
- Residing within the area serviced by supplier
- Provide written informed consent
- Willing and able to comply with the study protocol in the investigator's judgement
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 for patients on any qualifying treatment (tx) regimen; ECOG PS 0, 1, 2, or 3 for patients on ADT with or without second generation antiandrogen
- Ability to complete questionnaire(s) by themselves or with assistance
- Willingness to follow birth control requirements for males of reproductive potential
Who cannot join
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
Show all 17Show fewer
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction ≤ 6 months
- Wound healing disorder
- Or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)
- Anticipation of the need for major surgery during the course of study treatment
- Note: Concomitant radiation therapy during the study period is allowed
- Not cleared for treatment in home via social stability screening
- Patients who received at home treatment through involvement in another CCBW trial
- Note: Patients who enrolled in another CCBW trial but had to be withdrawn prior to initiating treatment in the home would still be eligible
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
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Cancer Center Clinical Trials Team, 507-293-6386
About this study
Official title: A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish patient-centeredness by comparing patient ratings of their overall cancer care experience in the clinic versus in the home.
II. To establish patient-centeredness by evaluating patient preferences regarding the location of cancer treatment delivery.
SAFETY OBJECTIVES:
- To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment by a home health provider with remote patient monitoring and Command Center support as measured by the incidence of grade 3+ adverse events at least possibly related to cancer treatment delivery.
II. To describe the incidence of acute care visits, emergency room visits, and hospitalizations during the entire study treatment period and by location of cancer treatment delivery (i.e., during in-clinic cancer treatment versus at-home cancer treatment).
III. To describe the incidence of avoidable (in the opinion of the treating physician) acute care visits, emergency room visits, and hospitalizations during at-home cancer treatment.
SECONDARY OBJECTIVE:
- To evaluate the impact of home cancer treatment delivery on patient-reported function and global health/quality of life, patient-reported symptoms, satisfaction, and clinical outcomes.
EXPLORATORY OBJECTIVES:
- To summarize patient perceptions and reasons for patient preferences regarding the location of cancer treatment delivery.
II. To describe overall survival. III. To assess the cost outcomes related to patient treatment in the clinic or in the home.
OUTLINE:
Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Being tested
- Cancer Therapeutic Procedure, Health Care Delivery, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Therapeutic ProcedureDrug
Also called anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm Therapy
Given standard of care cancer treatment in clinic
Cancer Therapeutic ProcedureDrug
Also called anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm Therapy
Given standard of care cancer treatment in home
Health Care DeliveryOther
Also called Care Delivery, Health Services Delivery, Other, Healthcare Delivery
Receive in home cancer treatment with CCBW
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (in clinic treatment, in home treatment) | Experimental | Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic. Receives: Drug: Cancer Therapeutic Procedure; Other: Health Care Delivery; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rating of overall cancer care experience - CAHPS
Patient rating of their overall cancer care experience after 12 weeks of at-home cancer treatment will be compared to the same rating after 6 or 12 weeks of in-clinic cancer treatment. Will be assessed using patient ratings from a single item from the Consumer Assessment of Healthcare Providers (CAHPS). Participants will rate "your overall cancer care experience" on a 0 to 10 scale where 0 is the worst experience possible and 10 is the best experience possible.
Measured: Up to 48 weeks
Patient preferences regarding the location of cancer treatment delivery
Will be assessed by a single item asking patients to rate their preferred location for cancer treatment delivery on a 1 to 7 scale: 1=strongly prefer in clinic, 2=moderately prefer in clinic, 3=slightly prefer in clinic, 4=no preference, 5=slightly prefer at home, 6=moderately prefer at home, 7=strongly prefer at home.
Measured: Up to 48 weeks
Incidence of grade 3+ adverse events (AEs)
Incidence, type, and severity of AEs experienced during the study period will be reported. The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For individual adverse events and overall, the frequency and proportion of grade 3+ adverse events and grade 3+ adverse events at least possibly related to cancer treatment delivery will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., in clinic versus at home).
Measured: Up to 30 days after last dose of study treatment
Acute care visits, emergency room visits, and hospitalizations
The frequency and proportion of patients who experience an acute care visit, emergency room visit, or hospitalization will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., during in clinic cancer treatment versus at-home cancer treatment).
Measured: Up to 48 weeks
Avoidable acute care visits, emergency room visits and hospitalizations
The frequency and proportion of patients who experience an avoidable acute care visit, emergency room visit, or hospitalization while receiving at-home cancer treatment will be reported. Whether an acute care visit, emergency room visit, or hospitalization could have been avoided from changing the location of cancer treatment delivery will be in the opinion of the treating physician.
Measured: Up to 48 weeks
Secondary outcomes (5)
Patient-reported function and global health status/quality of life
Will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Functioning 17 (QLQ-F17), scored following its published scoring algorithm. Higher scores indicate better quality of life
Measured: Up to 48 weeks
Patient-reported symptoms as measured by Patient Reported Outcomes (PRO)-CTCAE
PRO-CTCAE uses a 0-4 scoring system for most items, with 0 representing the absence of a symptom or no impact, and 4 representing the highest severity or impact. Some items, specifically those assessing presence, use a 0/1 (absent/present) scale. The frequency and proportion of patients with a maximum baseline-adjusted composite score ≥ 3 during the study treatment period and by location of cancer treatment delivery will be reported.
Measured: Up to 48 weeks
Patient-reported symptoms as measured by Functional Assessment of Cancer Therapy General Population 5 (FACT GP5)
The FACT GP5 consists of a single question, "I am bothered by side effects of treatment," rated on a scale of 0-4 where 0=not at all and 4=very much.
Measured: Up to 48 weeks.
Patient Satisfaction and Feedback Questionnaire
Patient satisfaction will be measured by the Patient Satisfaction and Feedback Questionnaire (specific to this study). The questionnaire consists of 30 questions evaluating different aspects of care, including level of care (excellent, very good, good, faire poor), preference for location of care (at home vs in clinic), comparison of care at home vs in clinic (strongly agree, disagree, neither agree nor disagree, agree, strongly agree), communication received from care team (0-10 where 0=worst communication possible and 10=best communication possible), transition to care at home and use of at-home equipment (very easy, easy, neither, difficult, very difficult). Patient responses will be summarized descriptively.
Measured: Up to 48 weeks
Patient satisfaction - Was It Worth It Questionnaire
Will be measured by the Was It Worth It Questionnaire, which consists of 3 questions answered with yes/no/undecided, two questions answered on a e-point scale (better, same, worse), and one open-ended question (one things that could have been done to improve patient experience). Patient responses will be summarized descriptively.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start22 Jan 2026
- Primary completion29 Sep 2028 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemically Recurrent Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Roxana S. Dronca, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073794
- Sponsor's protocol ID
- MC240507
- Other IDs
- NCI-2025-04662, 24-010825, MC240507, W81XWH-24-1-1106
- Status last verified
- Nov 2026
- First submitted
- 9 Jul 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07073794
- Acronym / sponsor ID
- MC240507
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 18 Jul 2025 (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.
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To establish patient-centeredness by comparing patient ratings of their overall cancer care experience in the clinic versus in the home.
II. To establish patient-centeredness by evaluating patient preferences regarding the location of cancer treatment delivery.
SAFETY OBJECTIVES:
- To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment by a home health provider with remote patient monitoring and Command Center support as measured by the incidence of grade 3+ adverse events at least possibly related to cancer treatment delivery.
II. To describe the incidence of acute care visits, emergency room visits, and hospitalizations during the entire study treatment period and by location of cancer treatment delivery (i.e., during in-clinic cancer treatment versus at-home cancer treatment).
III. To describe the incidence of avoidable (in the opinion of the treating physician) acute care visits, emergency room visits, and hospitalizations during at-home cancer treatment.
SECONDARY OBJECTIVE:
- To evaluate the impact of home cancer treatment delivery on patient-reported function and global health/quality of life, patient-reported symptoms, satisfaction, and clinical outcomes.
EXPLORATORY OBJECTIVES:
- To summarize patient perceptions and reasons for patient preferences regarding the location of cancer treatment delivery.
II. To describe overall survival. III. To assess the cost outcomes related to patient treatment in the clinic or in the home.
OUTLINE:
Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (in clinic treatment, in home treatment) | Experimental | Drug: Cancer Therapeutic Procedure, Other: Health Care Delivery, Other: Questionnaire AdministrationPatients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years
- Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines
- Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse [co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted]
- Patients who are anticipated to continue the treatment regimen they are currently prescribed for at least 18 weeks following registration (if on chemotherapy or immunotherapy) or 24 weeks following registration (for all other treatment regimens)
- Residing within the area serviced by supplier
Key exclusion criteria (17 listed)
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Uncontrolled intercurrent illness including, but not limited to:
- Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)
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 |
|---|---|---|
| Cancer Therapeutic ProcedureAlso: anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm TherapyGiven standard of care cancer treatment in clinic | Drug | Treatment (in clinic treatment, in home treatment) |
| Cancer Therapeutic ProcedureAlso: anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm TherapyGiven standard of care cancer treatment in home | Drug | Treatment (in clinic treatment, in home treatment) |
| Health Care DeliveryAlso: Care Delivery, Health Services Delivery, Other, Healthcare DeliveryReceive in home cancer treatment with CCBW | Other | Treatment (in clinic treatment, in home treatment) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (in clinic treatment, in home treatment) |
Primary outcome
Patient rating of overall cancer care experience - CAHPS
Time frame: Up to 48 weeks
Patient rating of their overall cancer care experience after 12 weeks of at-home cancer treatment will be compared to the same rating after 6 or 12 weeks of in-clinic cancer treatment. Will be assessed using patient ratings from a single item from the Consumer Assessment of Healthcare Providers (CAHPS). Participants will rate "your overall cancer care experience" on a 0 to 10 scale where 0 is the worst experience possible and 10 is the best experience possible.
Patient preferences regarding the location of cancer treatment delivery
Time frame: Up to 48 weeks
Will be assessed by a single item asking patients to rate their preferred location for cancer treatment delivery on a 1 to 7 scale: 1=strongly prefer in clinic, 2=moderately prefer in clinic, 3=slightly prefer in clinic, 4=no preference, 5=slightly prefer at home, 6=moderately prefer at home, 7=strongly prefer at home.
Incidence of grade 3+ adverse events (AEs)
Time frame: Up to 30 days after last dose of study treatment
Incidence, type, and severity of AEs experienced during the study period will be reported. The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For individual adverse events and overall, the frequency and proportion of grade 3+ adverse events and grade 3+ adverse events at least possibly related to cancer treatment delivery will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., in clinic versus at home).
Acute care visits, emergency room visits, and hospitalizations
Time frame: Up to 48 weeks
The frequency and proportion of patients who experience an acute care visit, emergency room visit, or hospitalization will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., during in clinic cancer treatment versus at-home cancer treatment).
Avoidable acute care visits, emergency room visits and hospitalizations
Time frame: Up to 48 weeks
The frequency and proportion of patients who experience an avoidable acute care visit, emergency room visit, or hospitalization while receiving at-home cancer treatment will be reported. Whether an acute care visit, emergency room visit, or hospitalization could have been avoided from changing the location of cancer treatment delivery will be in the opinion of the treating physician.
5 secondary outcomes
Patient-reported function and global health status/quality of life
Time frame: Up to 48 weeks
Patient-reported symptoms as measured by Patient Reported Outcomes (PRO)-CTCAE
Time frame: Up to 48 weeks
Patient-reported symptoms as measured by Functional Assessment of Cancer Therapy General Population 5 (FACT GP5)
Time frame: Up to 48 weeks.
Patient Satisfaction and Feedback Questionnaire
Time frame: Up to 48 weeks
Patient satisfaction - Was It Worth It Questionnaire
Time frame: Up to 48 weeks
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 6 Nov 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Roxana S. Dronca, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cancer Therapeutic Procedure, Health Care Delivery and Questionnaire Administration in people with Biochemically Recurrent Prostate Carcinoma and Locally Advanced Prostate Carcinoma, run by Mayo Clinic 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 18 inclusion and 17 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 6 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rating of overall cancer care experience - CAHPS (time frame: Up to 48 weeks). The study lists 5 primary outcomes in all. 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 6 Nov 2026.