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

ConditionMetastatic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Low Risk Prostate CancerExperimental treatment 3 interventions
Group B: High Risk Prostate CancerExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Radiological progression-free survival (rPFS)

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.

Time frame
36 months

Secondary outcomes

1

Overall survival (OS)

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.

Time frame
5 years
2

rPFS using PSMA PET/CT scan combined with PSA response

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

Time frame
5 years
3

Time to initiation of subsequent antineoplastic therapy

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

Time frame
5 years
4

Disease progression within 5 years of starting ADT for mCSPC

The number of patients with disease progression at 5 years

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgetown University

Lead sponsor

Lantheus Medical Imaging

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: