RightFit
RecruitingPhase 2

Castrate Resistant Prostate Cancer Enhertu Therapy

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Enhertu after other treatments for prostate cancer that has spread and keeps growing despite treatment to lower testosterone. It is for people with HER2-positive cancer, meaning their cancer has a protein called HER2.

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Lab tests confirm prostate adenocarcinoma, a cancer that starts in gland cells.
  • Cancer has spread and worsened during testosterone-lowering treatment and newer hormone drugs. Prior taxane chemotherapy is not required.
  • Still receiving androgen deprivation therapy (ADT) to keep testosterone below 50 ng/dL.
  • A preserved tumor sample is available for HER2 testing.
  • Expected to live 6 months.
  • Fully active or able to do light work, with limits on hard physical activity.
  • The heart pumps out at least 50% of the blood in its main pumping chamber with each beat.
  • Blood clotting, organs, bone marrow, kidneys, and liver work well enough.

Who can't join

  • Past lung tissue disease or lung inflammation that needed steroid treatment.
  • Serious disease in the blood vessels that supply the heart.
  • Past treatment with a drug that targets HER2.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the prostate * Diagnosis of mCRPC * Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen * Ongoing ADT to maintain serum testosterone levels below 50 ng/dL * Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry * Life expectancy 6 months * ECOG 0 or 1 * LVEF at least 50% * Adequate Blood Clotting function * Adequate Organ and Bone Marrow function * Adequate Renal function * Adequate Hepatic function Exclusion Criteria: * History of interstitial lung disease or pneumonitis requiring steroids * Significant coronary vascular disease * Previous exposure to HER2 targeted therapy

Study sites (1)

DC