RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorGeorgetown University

About this trial

This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by treatment de-escalation at the Medstar Health network. A pragmatic design will be implemented in order to make the study available to patients at greatest needs from minority populations in the community. Additional assessments include quality-of-life (QoL) and sexual function changes as well as correlative studies. A maximum of 108 patients will be enrolled in this study. The investigators hypothesize that with a risk-adapted treatment approach followed by treatment de-escalation, more than 50% of patients will have radiographic progression-free survival (rPFS) at 36 months. Additionally, the investigators hypothesize that the risk-stratified de-escalation approach will result in fewer treatment-related adverse events and better QoL, compared to historical controls.

Eligibility criteria

Qualifiers

Adult patients with metastatic castrate sensitive prostate cancer that are eligible for standard of care (SOC) per treating physician.

Patients who can give informed consent and are willing to comply with follow-up visits and treatment plans.

Disqualifiers

Patients for whom, in the opinion of the investigator, participation in the study, use of the drugs outlined in the study, or use of the risk-adapted treatment de-escalation strategy is not appropriate or safe.

Chemotherapy other than docetaxel for prostate cancer any time prior to enrollment;

Radiopharmaceuticals for prostate cancer any time prior to enrollment.

Patients who have received treatment with radiotherapy (EBRT, brachytherapy, or radiopharmaceuticals) within 2 weeks before prior to the start of study treatment.

Trial design

Treatments tested in this trial

  • Androgen Deprivation Therapy (ADT)
  • Androgen Receptor Pathway Inhibitor (ARPI)
  • Prostate Radiation
  • Docetaxel

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Georgetown University

Lead sponsor

Lantheus Medical Imaging

Collaborator