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NCT Number: NCT07645326

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

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.

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Key information

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Georgetown University Medical Center- Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location contact

Paul Leger, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

a. Low risk SOC: ADT + ARPI + radiation to the prostate i. For patients with low-risk disease (defined in Section 8.1), prior treatment with ADT or ARPI for up to 8 weeks for mCSPC is permitted; however, prior treatment with docetaxel is not allowed.

b. High risk SOC: ADT + ARPI +/- docetaxel i. For patients with high-risk disease (defined in Section 8.1), prior treatment with ADT, ARPI, or docetaxel for up to 8 weeks for mCSPC is permitted.

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

Exclusion criteria

  • 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.
  • Patients who have received prior treatment with any of the following:
  • 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.
  • Patients with prior treatment with an ARPI for non-metastatic disease within 6 months of diagnosis of metastatic disease are not eligible.

a. Note: Patients who were diagnosed with metastatic disease or more than 6 months after treatment with an ARPI non-metastatic disease are eligible.

  • Patients who had previous (within 28 days before the start of study drug or 4 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
  • Patients with an inability to swallow oral medications in the opinion of the clinical investigator.
  • Patients with leptomeningeal disease.

Treatment and study plan

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.

Other names: Taxotere, Docivyx, Docefrez, BEIZRAY

Primary outcomes

  1. Radiological progression-free survival (rPFS)

    Time frame: 36 months

    rPFS is defined as the time from the first dose of systemic therapy for mCSPC to the first documented radiological progression in soft tissue or bone, based on CT, MRI, or NM bone scan, using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for soft-tissue metastases and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases, or death from any cause.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

    OS is defined as the time from the date of treatment to death from any cause. OS at 5 years is defined as being alive at 5 years after starting of ADT.

  2. rPFS using PSMA PET/CT scan combined with PSA response

    Time frame: 5 years

    This is defined at the time from the first dose of systemic therapy for mCSPC to the time to progressive disease as measured by PSMA PET/CT scan (RECIP 1.0) combined with PSA response

  3. Time to initiation of subsequent antineoplastic therapy

    Time frame: 5 years

    Time to initiation of subsequent antineoplastic therapy is defined as the time from initiation of ADT to subsequent antineoplastic therapy for prostate cancer.

  4. Disease progression within 5 years of starting ADT for mCSPC

    Time frame: 5 years

    The number of patients with disease progression at 5 years

  5. Symptomatic skeletal event free (SSE) survival

    Time frame: 5 years

    SSE survival is defined as the time from first dose of systemic therapy for mCSPC to the first occurrence of SSE or death from any cause, whichever comes first. An SSE is defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.

  6. Time to pain progression

    Time frame: 5 years

    Time from start date of ADT to the first date a subject experiences a pain progression. Pain will be assessed using the PEG Scale (Pain, Enjoyment, General Activity) Questionnaire

  7. Adverse Events

    Time frame: 5 years

    Number of patients with an AE that resulted in treatment discontinuation.

  8. Quality-of-life changes per Functional Assessment of Cancer Therapy (FACT) Prostate Cancer Symptom Index - 17 (FACT-FPSI-17)

    Time frame: 3 months, 6 months, 9 month, 1 year

    Patients with changes to quality of life ans sexual function as measured by National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (FACT) Prostate Cancer Symptom Index - 17 Item Version (NCCN/FACT-FPSI-17). Score rage 0 to 68, a score of "0" is a severely symptomatic patient and the highest possible score is an asymptomatic patient.

  9. Quality-of-life changes per Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 3 months, 6 months, 9 month, 1 year

    Patients with changes to quality of life as measured by Brief Pain Inventory-Short Form (BPI-SF). Score range 0 to 10; a low score equals less pain severity and less pain interference, a higher score equals higher pain severity and interference.

  10. Development of osteoporosis

    Time frame: 5 years

    The number of patients that develope osteoporosis within 5 years on study

  11. Development of osteopenia

    Time frame: 5 years

    The number of patients that develope osteopenia within 5 years on study

  12. Prevalence of gynecomastia

    Time frame: 5 years

    The number of patients who develop Grade 1 to 3 Gynecomastia;

Study contacts

Contact information is provided by the study sponsor or research team.

Paul D Leger, MD

CONTACT

[email protected]

202-444-2223

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Lantheus Medical Imaging

Registry information

Official study title

A Pragmatic Phase 2 Trial of Risk-Adapted Treatment Approaches Including Treatment De-escalation to Minimize Adverse Effects of Hormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.

Acronym: RISK-ADAPT

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jun 12, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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