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Antiandrogen

Apalutamide + Targeted Radiation for Prostate Cancer

Phase 3
Recruiting
Led By Neha Vapiwala
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether adding apalutamide to standard treatment, with or without targeted radiation therapy, helps patients with prostate cancer that has come back after treatment.

Who is the study for?
Men with prostate cancer that has returned after surgery, evidenced by rising PSA levels. They must be suitable for standard radiation and hormone therapy, have no spread of cancer outside the pelvis as confirmed by imaging, and meet specific health criteria like adequate blood counts and liver function.
What is being tested?
The trial is testing if adding apalutamide (a drug blocking male hormones used by tumor cells) to standard care improves outcomes in patients whose prostate cancer has returned post-surgery. It also examines whether targeted radiation based on PET scan results offers additional benefits.
What are the potential side effects?
Apalutamide can cause fatigue, high blood pressure, skin rash, falls or fractures due to bone weakness. Radiation may lead to urinary issues or bowel discomfort. The combination could increase the risk of these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have inflammatory bowel disease or any condition that affects how my body absorbs food.
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My kidney function tests are within normal limits.
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I can lie still for 20-30 minutes for a scan or radiation treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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I am a man and at least 18 years old.
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I had surgery to remove my prostate due to cancer.
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I have not had seizures or conditions that could lead to seizures in the last year.
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I am eligible for radiation and hormone therapy after prostate surgery.
Select...
My cancer has returned after prostate surgery.
Select...
I have never had radiation therapy to my pelvic area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
PFS prolongation in patients with PET-evidence of extrapelvic metastases
PFS prolongation in patients without PET-evidence of extrapelvic metastases
Progression-free survival (PFS)
+1 more
Secondary study objectives
Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Comparison - Functional Assessment of Cancer Therapy (FACT)- prostate (P)
Concordance of detection rate with the follow-up conventional imaging modalities (CIM)
+9 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Fall
27%
Pain
27%
Dyspnea
27%
Depression
27%
Platelet count decreased
27%
Anemia
27%
Lymphocyte count decreased
20%
Chills
20%
Dizziness
20%
Edema limbs
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
13%
Edema
13%
Dysesthesia
13%
Dysgeusia
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Myalgia
13%
Rash
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Proteinuria
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Headaches
7%
Acute kidney injury
7%
Hypokalemia
7%
Oral lesions
7%
Lymphocytopenia
7%
Neutrophil count decreased
7%
Weakness (facial)
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Creatinine increased
7%
Headache
7%
Death NOS
7%
Gait disturbance
7%
Nasal congestion
7%
Fever
7%
Tremor
7%
Urinary urgency
7%
Hypoxic respiratory failure
7%
Amnesia
7%
Photophobia
7%
Pleural effusion
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Muscle weakness
7%
Erythema multitforme
7%
Lung infection
7%
Hypertension
7%
Allergy (seasonal)
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

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 D (EBRT, STAD, apalutamide, RT)Experimental Treatment18 Interventions
STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity.
Group II: Arm C (EBRT, STAD, apalutamide)Experimental Treatment13 Interventions
STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.
Group III: Arm B (EBRT, STAD, apalutamide)Experimental Treatment13 Interventions
STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Group IV: Arm A (EBRT, short-term androgen deprivation therapy [STAD])Active Control12 Interventions
STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin
2017
Completed Phase 4
~1560
Relugolix
2016
Completed Phase 3
~5360
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Degarelix
2002
Completed Phase 3
~3730
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Apalutamide
2015
Completed Phase 2
~5660
Positron Emission Tomography
2011
Completed Phase 2
~2200
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Goserelin Acetate
2007
Completed Phase 3
~1040
Volume Modulated Arc Therapy
2017
Completed Early Phase 1
~30
Intensity-Modulated Proton Therapy
2019
N/A
~10
Leuprolide Acetate
2002
Completed Phase 3
~1890
Computed Tomography
2017
Completed Phase 2
~2740

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
120 Previous Clinical Trials
179,073 Total Patients Enrolled
2 Trials studying Prostate Cancer
683 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,898 Previous Clinical Trials
41,011,909 Total Patients Enrolled
516 Trials studying Prostate Cancer
337,414 Patients Enrolled for Prostate Cancer
Neha VapiwalaPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Prostate Cancer
10 Patients Enrolled for Prostate Cancer

Media Library

Apalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT04423211 — Phase 3
Prostate Cancer Research Study Groups: Arm D (EBRT, STAD, apalutamide, RT), Arm B (EBRT, STAD, apalutamide), Arm C (EBRT, STAD, apalutamide), Arm A (EBRT, short-term androgen deprivation therapy [STAD])
Prostate Cancer Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT04423211 — Phase 3
Apalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04423211 — Phase 3
~536 spots leftby Dec 2032
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