Grand Rapids, MINCT07244341Now EnrollingIRB Ready

Metastatic Castration-resistant Prostate Cancer Clinical Trial in Grand Rapids, MI

Access cutting-edge metastatic castration-resistant prostate cancer treatment through this clinical trial at a research site in Grand Rapids. Study-provided care at no cost to qualified participants.

Sponsored by Daiichi Sankyo

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Expert Care in Grand Rapids

Access metastatic castration-resistant prostate cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic castration-resistant prostate cancer treatment provided free

Apply for This Grand Rapids Location

Check if you qualify for this metastatic castration-resistant prostate cancer clinical trial in Grand Rapids, MI

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Grand Rapids

    Convenient for MI 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 Grand Rapids site if eligible
  4. 4Begin participation

About This Metastatic Castration-resistant Prostate Cancer Study in Grand Rapids

This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).

Sponsor: Daiichi Sankyo

Who Can Participate

Inclusion Criteria

The clinical site will screen for the full inclusion criteria per protocol.
Adult males ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old).
Histologically confirmed adenocarcinoma of the prostate. Cases exhibiting neuroendocrine differentiation are eligible for enrollment, except those with a diagnosis of pure small cell carcinoma, which is excluded.
Evidence of disease progression as per the PCWG3 modified RECIST v1.1 criteria.
Evidence of metastatic disease as confirmed by radiographic imaging (CT, MRI, or bone scan).
Ongoing androgen deprivation at time of enrollment. • For participants currently being treated with luteinizing hormone-releasing hormone agonists or antagonists, therapy must have been initiated at least 4 weeks prior to enrollment and treatment must be continued throughout the trial.
Baseline PSA expression level of ≥2 ng/mL, according to a documented testing result.
Prior therapy with an Androgen Receptor Pathway Inhibitors (ARPI).
ECOG PS of 0 or 1 assessed no more than 28 days prior to enrollment.
Is willing and able to provide adequate fresh or archival tumor samples with sufficient quantity and tissue quality. A mandatory newly obtained pretreatment biopsy is required, if not clinically contraindicated and at an acceptable risk as determined by the investigator. If newly obtained tissue samples are not possible to obtain, archival tissue obtained from a lesion not previously irradiated and collected after the most recent prior therapy is acceptable.
A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each trial intervention. The length of time required to continue contraception after the last dose for each trial intervention is 3 months.
Must not freeze or donate sperm starting at screening and throughout the Treatment Period, and for at least 3 months after the final trial intervention administration. Note: Preservation of sperm should be considered before enrollment in this trial. • Adhere to either of the following contraception methods:
True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the participant, OR
Uses a penile/external condom when having penile-vaginal intercourse with an NPOCBP, PLUS partner use of an additional contraceptive method, as a condom may break or leak Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. If the contraception requirements in the local label for any trial interventions are more stringent than those above, the local label requirements are to be followed. Key

Exclusion Criteria

The clinical site will screen for the full exclusion criteria per protocol.
Prior treatment with any epigenetic agents including but not limited to EZH1, EZH2, EZH1/2, or PRC2 inhibitors.
Has a super scan as seen in the baseline bone scan. A super scan is 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.
Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Uncontrolled or significant cardiovascular disease,
Prior malignancy, active within the previous 3 years except for locally curable cancers that have been apparently cured or successfully resected, such as basal or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the stomach, or carcinoma in situ of the breast.
Has active or uncontrolled HBV infection.
Has active or uncontrolled HCV infection.
Has active or uncontrolled HIV 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 Grand Rapids?

Yes, this clinical trial (NCT07244341) has an active research site in Grand Rapids, MI 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 Treatment Options in Grand Rapids, MI

If you're searching for metastatic castration-resistant prostate cancer treatment options in Grand Rapids, MI, this clinical trial (NCT07244341) 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 Grand Rapids research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic castration-resistant prostate cancer 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 clinical trials near you to find additional studies recruiting in your area.

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