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Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

ConditionsProstate AdenocarcinomaStage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.

Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:

1. Comprehensive cardiac and exercise testing before and after starting ADT 2. Completion of quality-of-life questionnaires at specific intervals during the study period 3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration.

Prostate-specific antigen (PSA) 10-20 ng/mL

Clinical stage tumor (T)2b-c (digital rectal exam [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition

Gleason Score 7 (Gleason 3+4 or 4+3 [International Society of Urological Pathology [ISUP] grade group 2-3])

Disqualifiers

Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, High-intensity focused ultrasound (HIFU), laser thermal ablation, etc.) for prostate cancer.

Definitive clinical or radiologic evidence of metastatic disease (M1).

Prior invasive malignancy (except non-melanomatous skin cancer) or hematologic malignancy unless disease free for a minimum of 3 years.

Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Contrast Agent

    Other intervention

    Given IV

  • Leuprolide

    Drug

    Given injection

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Physical Performance Testing

    Other intervention

    Undergo functional fitness tests

  • Relugolix

    Drug

    Given PO

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Arm 1 (leuprolide)Experimental treatment 5 interventions
Group B: Arm 2 (relugolix)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Physiologic alterations in cardiopulmonary function - Myocardial perfusion

We will measure the difference in myocardial perfusion with exercise stress-rest cardiac MRI before and after ADT (leuprolide vs. relugolix).

Time frame
Up to 6 months
2

Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption

We will measure the difference in VO2 Max before and after ADT (leuprolide vs. relugolix).

Time frame
Up to 6 months

Secondary outcomes

1

Quality of life using EPIC-26

Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale. Overall, higher scores across the EPIC domains represent better QoL.

Time frame
Up to 6 months
2

Quality of life using EORTC QLQ-C30

All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning.

Time frame
Up to 6 months
3

Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L)

This validated utility assessment instrument evaluates 5-dimensions (5D) of function, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each graded on 5 levels (ranging from 1 \[no problem\] to 5 \[extreme problems\]). The 5D index score is transformed into a utility score between 0 and 1. The sixth item is a visual analogue scale for overall health perceived by the patient. A lower score represents better health.

Time frame
Up to 6 months
4

Quality of life using PROMIS

A 5-point Likert scale from 1 (never/not at all) to 5 (almost always/very much) with a recall period of last 7 days. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

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

Ohio State University Comprehensive Cancer Center

Lead sponsor

Pfizer

Collaborator

Sumitomo Pharma America, Inc.

Collaborator

Source ClinicalTrials.gov
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