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Hormone Therapy

Hormone + Radiation Therapy for Prostate Cancer

Phase 3

Recruiting

Led By Paul L Nguyen

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Appropriate stage for study entry based on the following diagnostic workup: History/physical examination within 120 days prior to registration; Bone imaging within 120 days prior to registration; Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by ≥10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure ≥ 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study Age ≥ 18 Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration) Platelet count ≥ -100 x 10^3/uL independent of transfusion and/or growth factors (within 120 days prior to registration) Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration) For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility Either a CrCl ≥ 30 ml/min or calculated glomerular filtration rate (GFR) ≥ 30 will make a patient eligible Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration) Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within 120 days prior to registration) Serum albumin ≥ 3.0 g/dL (within 120 days prior to registration) The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count ≥ 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Confirmation of Decipher score

Gleason score of 8-10

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 13 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two different intensities of hormone therapy and radiation therapy, comparing them to the current standard of care, in order to determine the best treatment plan for patients with high risk prostate cancer.

Who is the study for?

Men over 18 with high-risk prostate cancer, no metastatic disease outside the pelvis, and a good performance status can join. They must have had no prior chemotherapy for prostate cancer in the last 3 years, no radical prostatectomy or pelvic radiotherapy, and not be on certain medications like 5-alpha reductase inhibitors at randomization.

What is being tested?

The trial is testing less intense vs usual hormone therapy plus radiation for patients with low gene risk scores. For those with high gene risk scores, it's comparing more intense treatment (adding apalutamide) to usual care. The goal is to see if these approaches control cancer better without spreading.

What are the potential side effects?

Possible side effects include hot flashes, fatigue, sexual dysfunction from hormone therapies like Histrelin or Leuprolide; skin irritation from radiation; liver issues from Apalutamide; and gastrointestinal problems affecting medication absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is aggressive (Gleason score 8-10).

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My cancer has spread to my lymph nodes, which are enlarged.

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My cancer is classified as stage T3a to T4 based on exams or imaging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 13 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 13 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metastasis-free survival (MFS)

Secondary study objectives

Incidence of adverse events

MFS

Overall survival

+2 more

Other study objectives

Bowel and urinary quality of life (De-intensification study)

Cognition (De-intensification study)

Cognition (Intensification study)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm IV (intensification study)Experimental Treatment10 Interventions

Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide PO QD. Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (de-intensification study)Experimental Treatment11 Interventions

Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (de-intensification study)Active Control11 Interventions

Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

Group IV: Arm III (intensification study)Active Control11 Interventions

Patients undergo RT over 2-11 weeks and receive ADT as in Arm I.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Triptorelin

2017

Completed Phase 4

~1560

Degarelix

2002