Is NCT06136650 recruiting in Redlands, CA?

Yes, NCT06136650 is currently recruiting participants at its Redlands, CA location. This metastatic castration-resistant prostate cancer (mcrpc) clinical trial is actively enrolling qualified participants.

Is participation in this Redlands 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.

Metastatic Castration-resistant Prostate Cancer (mCRPC) Clinical Trial in Redlands, CA

Q: How do I join the metastatic castration-resistant prostate cancer (mcrpc) clinical trial in Redlands?

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

About This Metastatic Castration-resistant Prostate Cancer (mCRPC) Study in Redlands

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Sponsor: Merck Sharp & Dohme LLC

Who Can Participate

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology

Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening

Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)

Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \[mHSPC\] or non-metastatic hormone-sensitive prostate cancer \[nmHSPC\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \[mCRPC\] or non-metastatic castration-resistant prostate cancer \[nmCRPC\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel

Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment

Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)

Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization

Has adequate organ function

Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed

Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization

Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible

Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

Has presence of gastrointestinal condition

Is unable to swallow capsules/tablets

Has history of pituitary dysfunction

Has poorly controlled diabetes mellitus

Has clinically significant abnormal serum potassium or sodium level

Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy

Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events

History or family history of long QTc syndrome

Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment

Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place

Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)

Has not adequately recovered from major surgery or have ongoing surgical complications

Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures

Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention

Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids

Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention

Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention

Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention

Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration

Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat

Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated

Has known additional malignancy that is progressing or has required active treatment within the past 3 years

Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention

Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed

Active infection requiring systemic therapy

Has concurrent active Hepatitis B virus and Hepatitis C virus infection

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 Redlands?

Yes, this clinical trial (NCT06136650) has an active research site in Redlands, CA 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 Castration-resistant Prostate Cancer (mCRPC) Treatment Options in Redlands, CA

If you're searching for metastatic castration-resistant prostate cancer (mcrpc) treatment options in Redlands, CA, this clinical trial (NCT06136650) 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 Redlands research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic castration-resistant prostate cancer (mcrpc) 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 castration-resistant prostate cancer (mcrpc) clinical trials near you to find additional studies recruiting in your area.

Metastatic Castration-resistant Prostate Cancer (mCRPC) Clinical Trial in Redlands, CA

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