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Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer

ConditionMetastatic Hormone-sensitive Prostate Cancer (mHSPC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Utah

About this trial

The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant aged ≥ 18 years

Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology.

Metastasis detected any time prior to study registration on conventional or functional imaging as determined by the treating investigator and can be of any site.

Baseline testosterone >50 ng/dl before start of therapy for metastatic disease

Disqualifiers

Participant received androgen deprivation therapy (defined as leuprolide or surgical castration) for metastatic hormone-sensitive prostate cancer.

The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.

Known brain metastases or cranial epidural disease.

Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • relugolix + ARPI

    Drug

    Step 1: Continuous treatment with relugolix + ARPI

  • Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI

    Drug

    Intermittent treatment with relugolix + ARPI.

  • relugolix or androgen deprivation therapy (ADT) + ARPI

    Drug

    Step 2: Standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI.

  • relugolix + ARPI.

    Drug

    Step 2: Intermittent treatment with relugolix + ARPI.

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: Cohort A: Arm 1Active comparator 2 interventions
Group B: Cohort A: Arm 2Experimental treatment 2 interventions
Group C: Cohort BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization.

To assess the difference in fatigue 6 months after randomization in patients with mHSPC achieving optimal PSA response on intermittent relugolix + ARPI versus continuous relugolix/ADT + ARPI. Scored from 0 (no Fatigue) to 10 (as bad as you can imagine), and 0 (Does not interfere) to 10 (Completely Interferes).

Time frame
6 months
2

Cohort B: Progression-free survival (PFS) as defined as the time from intermittent study initiation (first treatment break) to the time of documented disease progression or death from any cause at one year.

To assess PFS in patients with mHSPC on intermittent relugolix/ADT + ARPI at one year.

Time frame
12 months

Secondary outcomes

1

Changes in health-related quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQC30).

To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQC30 scored from 1 (not at all)- 4 (very much).

Time frame
13 months
2

Changes in health-related quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-PR25).

To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQ-PR25 scored from 1 (not at all)- 4 (very much).

Time frame
13 months
3

Sexual function improvement in those with intact sexual function at baseline as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire.

To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQ-PR25, question 52-55.Scored from 1 (not at all)- 4 (very much).

Time frame
13 months
4

Changes in severity of hot flashes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS).

To evaluate treatment effects on patient-reported outcomes (PROs). HFRDIS scored 0 (did not interfere to 10 (completely interfered).

Time frame
13 months

Other outcomes

Sponsors and contacts

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

University of Utah

Lead sponsor

Source ClinicalTrials.gov
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