Is NCT07073794 recruiting in Jacksonville, FL?

Yes, NCT07073794 is currently recruiting participants at its Jacksonville, FL location. This biochemically recurrent prostate carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Biochemically Recurrent Prostate Carcinoma Clinical Trial in Jacksonville, FL

Q: How do I join the biochemically recurrent prostate carcinoma clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Biochemically Recurrent Prostate Carcinoma Study in Jacksonville

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.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT07073794) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Biochemically Recurrent Prostate Carcinoma Treatment Options in Jacksonville, FL

If you're searching for biochemically recurrent prostate carcinoma treatment options in Jacksonville, FL, this clinical trial (NCT07073794) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced biochemically recurrent prostate carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all biochemically recurrent prostate carcinoma clinical trials near you to find additional studies recruiting in your area.

Biochemically Recurrent Prostate Carcinoma Clinical Trial in Jacksonville, FL

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