Salt Lake City, UTNCT07216248Now EnrollingIRB Ready

Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Clinical Trial in Salt Lake City, UT

Access cutting-edge metastatic hormone-sensitive prostate cancer (mhspc) treatment through this clinical trial at a research site in Salt Lake City. Study-provided care at no cost to qualified participants.

Sponsored by University of Utah

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Expert Care in Salt Lake City

Access metastatic hormone-sensitive prostate cancer (mhspc) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic hormone-sensitive prostate cancer (mhspc) treatment provided free

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Check if you qualify for this metastatic hormone-sensitive prostate cancer (mhspc) clinical trial in Salt Lake City, UT

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Why Participate?

  • No-Cost Study Care

  • Local to Salt Lake City

    Convenient for UT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Salt Lake City site if eligible
  4. 4Begin participation

About This Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Study in Salt Lake City

The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.

Sponsor: University of Utah

Who Can Participate

Inclusion Criteria

Cohort A Eligibility (Step 1 Registration)
Participant aged ≥ 18 years
Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology.
Metastasis detected any time prior to study registration on conventional or functional imaging as determined by the treating investigator and can be of any site.
Baseline testosterone \>50 ng/dl before start of therapy for metastatic disease
PSA ≥ 1 ng/mL before start of therapy for metastatic disease
ECOG Performance Status ≤ 2
Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.
Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.
If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.
Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.
Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator.
Has access to a smartphone and wireless services and is able to download and navigate study specific applications.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Cohort A Eligibility (Step 2 Registration) -PSA ≤ 0.2 ng/mL after 6-12 months of relugolix and androgen receptor pathway inhibitor treatment. Androgen receptor pathway inhibitor includes abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs. Cohort B Eligibility
Participant aged ≥ 18 years
Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology.
Metastasis detected any time prior to study registration on conventional or functional imaging as determined by clinical investigator and can be of any site.
PSA ≤ 0.2 ng/mL after treatment with androgen deprivation therapy or androgen receptor pathway inhibitor treatment or both of any duration. Androgen deprivation therapy in this context includes gonadotropin-releasing hormone agonists and antagonists. Androgen receptor pathway inhibitors include abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs.
Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.
Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.
If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.
Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.
Has access to a smartphone and wireless services and is able to download and navigate study specific applications.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria

Cohort A Eligibility (Step 1 Registration)
Participant received androgen deprivation therapy (defined as leuprolide or surgical castration) for metastatic hormone-sensitive prostate cancer.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Known brain metastases or cranial epidural disease. --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry.
Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation.
Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
Participants taking prohibited medications as described in Section 6.6.2. Cohort A Eligibility (Step 2 Registration)
Receiving other systemic anti-cancer therapy for prostate cancer. Prior treatment before Step 2 registration is allowed.
Progression to metastatic castration-resistant prostate cancer per clinical investigator.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Participants taking prohibited medications as described in Section 6.6.2. Cohort B Eligibility
Receiving other systemic anti-cancer therapy for prostate cancer.
History of surgical castration.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Known brain metastases or cranial epidural disease. --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry
Current evidence of uncontrolled, significant intercurrent illness, infection, compliance or other safety concerns which may affect clinical trial participation.
Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
Participants taking prohibited medications as described in Section 6.6.1.

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 Salt Lake City?

Yes, this clinical trial (NCT07216248) has an active research site in Salt Lake City, UT 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.

Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Treatment Options in Salt Lake City, UT

If you're searching for metastatic hormone-sensitive prostate cancer (mhspc) treatment options in Salt Lake City, UT, this clinical trial (NCT07216248) 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 Salt Lake City research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic hormone-sensitive prostate cancer (mhspc) 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 metastatic hormone-sensitive prostate cancer (mhspc) clinical trials near you to find additional studies recruiting in your area.

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