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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
79%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Dehydration
7%
Blurred vision
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Otitis externa
7%
Creatinine increased
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Hypertension
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

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
~1370
Relugolix
2016
Completed Phase 3
~5360
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Degarelix
2002
Completed Phase 3
~3600
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Apalutamide
2015
Completed Phase 2
~3310
Positron Emission Tomography
2008
Completed Phase 2
~2240
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
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
~2720

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,118 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,922 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,923,717 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 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 B (EBRT, STAD, apalutamide), Arm D (EBRT, STAD, apalutamide, RT), 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Stereotactic Body Radiation Therapy been cleared by the FDA?

"There is some evidence Stereotactic Body Radiation Therapy works, as well as multiple rounds of data supporting its safety, so it received a score of 3."

Answered by AI

Are there precedents for using Stereotactic Body Radiation Therapy in this way?

"Stereotactic Body Radiation Therapy was first researched in the year 2000 at Centre de Recherche Clinique du CHUS. Since then, 1057 studies have been completed with 267 more currently underway. There is a large number of these active trials taking place out of Philadelphia, Pennsylvania."

Answered by AI

What are the most common conditions that doctors use Stereotactic Body Radiation Therapy to treat?

"Stereotactic Body Radiation Therapy can be used to help patients with cervical syndrome, burns that are not severe, and stage t2b prostate cancer."

Answered by AI

Are there any more spots open for volunteers in this research project?

"The trial, which was first announced on October 8th 2020, is still seeking patients according to the latest update from clinicaltrials.gov on May 16th 2022."

Answered by AI

Why did researchers design this experiment in this particular way?

"The primary outcome of this long-term study is to see if PFS prolongation in patients with PET-evidence of extrapelvic metastases. Additionally, the concordance of detection rate with the follow-up conventional imaging modalities and value of repeat PET to assess response to therapy will be compared to standard response assessments."

Answered by AI

How many people are included as test subjects in this experiment?

"In total, 804 individuals that fit the pre-determined inclusion criteria are required for this research project. Patients can go to one of many sites such as Fox Chase Cancer Center in Philadelphia, Pennsylvania or Siteman Cancer Center-South County in Saint Louis, Missouri."

Answered by AI

Does this trial break new ground in the medical community?

"There are 267 ongoing studies investigating Stereotactic Body Radiation Therapy in 1641 locations, across 62 countries. The first such study was sponsored by AstraZeneca in the year 2000 and completed Phase 3 drug approval with 600 patients enrolled. In the 20 years since then, 1057 similar clinical trials have been completed."

Answered by AI

How many different medical clinics are participating in this study?

"This clinical trial currently has 35 patients enrolled, with locations including the Fox Chase Cancer Center in Philadelphia, Siteman Cancer Center-South County in Saint Louis, Seattle Cancer Care Alliance in Saint Peters, and other centres."

Answered by AI

Who else is applying?

What site did they apply to?
University of Mississippi Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
2020. "Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04423211.
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~536 spots leftby Dec 2032
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