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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT07645326
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Androgen Deprivation Therapy (ADT) — DRUG
    ADT, Gonadotropin-releasing hormone (GnRH) agonist or antagonists, as prescribed by the treating physician.
  • Androgen Receptor Pathway Inhibitor (ARPI) — DRUG
    Darolutamide is the preferred ARPI for this study; however, patients may receive abiraterone, apalutamide, or enzalutamide at the discretion of their oncologist and based on patient preference.
  • Prostate Radiation — RADIATION
    prostate radiation, with or without radiation to metastatic sites
  • Docetaxel — DRUG
    Docetaxel will be administered as prescribed by the treating physician.

Study Details

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. We 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, we hypothesize that the risk-stratified de-escalation approach will result in fewer treatment-related adverse events and better QoL, compared to historical controls.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2032
Completion
Aug 31, 2032

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Risk Prostate Cancer
    Low risk patients will receive 6-month doublet therapy with Androgen Deprivation Therapy (ADT) + Androgen Receptor Pathway Inhibitor (ARPI) + prostate radiation with or without radiation to metastatic sites followed by 30 months ARPI monotherapy. At a 36-month timepoint, those who maintain a prostate specific antigen (PSA) ≤ 0.2ng/mL will have the option to either discontinue treatment proceeding with active surveillance or continue on their ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans \[CT/MRI imaging per modified RECIST 1.1 or bone scan per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)\], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
  • Experimental: High Risk Prostate Cancer
    High-risk patients will receive triplet therapy with ADT + ARPI + 6 cycles of docetaxel followed by 18-months of ADT + ARPI and then 12-month ARPI monotherapy. If a patient has high-risk disease but, based on the investigator's judgment, has contraindications to docetaxel or is deemed unsuitable for it, they will receive the same treatment regimen as other high-risk patients minus the docetaxel. Then at a 36-month timepoint, those who maintain a PSA ≤ 0.2ng/mL will have the option to either discontinue treatment with active surveillance or continue ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA (nadir) on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans \[CT/MRI imaging per modified RECIST 1.1 or bone scan per PCWG3\], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.

Primary Outcome Measure

Radiological progression-free survival (rPFS) [ Time Frame: 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown University Medical Center- Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Paul Leger, MD (PRINCIPAL_INVESTIGATOR)

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Georgetown University Medical Center- Lombardi Comprehensive Cancer Center· Washington D.C., DC

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