RECRUITING

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer

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Conditions

Biochemically Recurrent Prostate CarcinomaLocally Advanced Prostate CarcinomaMetastatic Prostate CarcinomaStage III Prostate Cancer AJCC v8Stage IV Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08-27
Study Completion:2028-08-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07073794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * 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 \[co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted\]
  3. * Androgen deprivation therapy (ADT):
  4. * Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length
  5. * Degarelix SQ, 4 weeks cycle length
  6. * Chemotherapy: Cabazitaxel IV, 3 weeks cycle length
  7. * Immunotherapy: Pembrolizumab IV, 3 weeks cycle length
  8. * Bone modifying agent + any of the prostate cancer treatments:
  9. * Zoledronic acid IV, 4 or 12 weeks cycle length
  10. * Denosumab SQ, 4 or 12 weeks cycle length
  11. * 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)
  12. * Residing within the area serviced by supplier
  13. * Provide written informed consent
  14. * Willing and able to comply with the study protocol in the investigator's judgement
  15. * 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
  16. * Ability to complete questionnaire(s) by themselves or with assistance
  17. * Willingness to follow birth control requirements for males of reproductive potential
  1. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  2. * Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
  3. * 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
  4. * Uncontrolled intercurrent illness including, but not limited to:
  5. * Ongoing or active infection
  6. * Symptomatic congestive heart failure
  7. * Unstable angina pectoris
  8. * Cardiac arrhythmia
  9. * Myocardial infarction ≤ 6 months
  10. * Wound healing disorder
  11. * Or psychiatric illness/social situations that would limit compliance with study requirements
  12. * 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)
  13. * Anticipation of the need for major surgery during the course of study treatment
  14. * Note: Concomitant radiation therapy during the study period is allowed
  15. * Not cleared for treatment in home via social stability screening
  16. * Patients who received at home treatment through involvement in another CCBW trial
  17. * Note: Patients who enrolled in another CCBW trial but had to be withdrawn prior to initiating treatment in the home would still be eligible

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Roxana S. Dronca, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Roxana S. Dronca, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-27
Study Completion Date2028-08-27

Study Record Updates

Study Start Date2025-08-27
Study Completion Date2028-08-27

Terms related to this study

Additional Relevant MeSH Terms

  • Biochemically Recurrent Prostate Carcinoma
  • Locally Advanced Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Stage III Prostate Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8