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Apalutamide + Hormone and Radiation Therapies for Prostate Cancer (INNOVATE Trial)
Phase 3
Recruiting
Led By Ronald C Chen
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
Be older than 18 years old
Must not have
History of any of the following: Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy), Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration, New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification.), History of any condition that in the opinion of the investigator, would preclude participation in this study
Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. fluciclovine F-18 PET, F-18 PSMA, PSMA, F-18 choline 11)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7.5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether adding apalutamide to the standard treatment of surgery and radiation therapy can improve outcomes for patients with lymph node positive prostate cancer.
Who is the study for?
Men with prostate cancer who've had surgery and have lymph node involvement but no distant metastasis. They must have a detectable PSA level post-surgery, good organ function, and be on or willing to start hormone therapy. Excluded are those currently on certain medications, with recent seizures or severe cardiovascular events, uncontrolled infections or hypertension, inability to swallow pills, inflammatory bowel disease, prior chemotherapy for prostate cancer, or overlapping radiation treatment.
What is being tested?
The trial is testing if adding Apalutamide to usual hormone therapy plus radiation after surgery can better prevent the spread of prostate cancer compared to standard treatment alone. It's a phase III study where patients receive high energy x-rays and drugs that block male hormones which may fuel cancer growth.
What are the potential side effects?
Apalutamide may cause fatigue, high blood pressure, skin rash, falls and fractures due to bone weakness; it could also affect liver function tests. Hormone therapy might lead to hot flashes and sexual dysfunction while radiation can cause skin irritation at the treated site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with prostate cancer and had surgery to remove it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My scans show cancer has spread to distant parts of my body.
Select...
I've had radiation in the same area where my current cancer is located.
Select...
I have received hormone therapy before prostate surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7.5 years
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
Biochemical progression-free survival (bPFS)
Cancer-specific survival
Incidence of adverse events
+4 moreOther study objectives
MFS by Decipher genomic score
OS by Decipher genomic score
PAM50-based classification of prostate cancer
Side effects data
From 2023 Phase 3 trial • 500 Patients • NCT0349385473%
Alopecia
70%
ALOPECIA
62%
Nausea
60%
NAUSEA
59%
Diarrhoea
55%
DIARRHOEA
43%
Anaemia
41%
ANAEMIA
33%
Arthralgia
33%
Asthenia
30%
ASTHENIA
27%
Headache
25%
Neutropenia
25%
Fatigue
24%
Stomatitis
24%
STOMATITIS
24%
NEUTROPENIA
22%
Rash
22%
FATIGUE
21%
Myalgia
21%
Radiation skin injury
21%
Neutrophil count decreased
21%
Constipation
21%
CONSTIPATION
20%
Alanine aminotransferase increased
20%
Decreased appetite
20%
Vomiting
20%
HEADACHE
19%
Mucosal inflammation
19%
ALANINE AMINOTRANSFERASE INCREASED
19%
MUCOSAL INFLAMMATION
19%
NEUTROPHIL COUNT DECREASED
18%
DECREASED APPETITE
18%
VOMITING
18%
ARTHRALGIA
17%
RASH
17%
MYALGIA
16%
Neuropathy peripheral
16%
Peripheral sensory neuropathy
16%
Aspartate aminotransferase increased
16%
Cough
16%
Pyrexia
15%
Epistaxis
15%
Hot flush
15%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
Insomnia
14%
Dysgeusia
14%
PYREXIA
14%
Nasopharyngitis
14%
White blood cell count decreased
14%
Infusion related reaction
14%
Leukopenia
14%
DYSGEUSIA
13%
Dizziness
13%
LEUKOPENIA
13%
INFUSION RELATED REACTION
13%
Dry skin
13%
EPISTAXIS
13%
PERIPHERAL SENSORY NEUROPATHY
12%
Dyspepsia
12%
DRY SKIN
12%
NEUROPATHY PERIPHERAL
12%
COUGH
12%
WHITE BLOOD CELL COUNT DECREASED
11%
INSOMNIA
10%
Upper respiratory tract infection
10%
DYSPEPSIA
10%
Pruritus
10%
Pain in extremity
10%
Ejection fraction decreased
10%
HOT FLUSH
10%
Oedema peripheral
10%
Procedural pain
9%
Paraesthesia
9%
UPPER RESPIRATORY TRACT INFECTION
9%
PROCEDURAL PAIN
9%
DIZZINESS
9%
Hypokalaemia
8%
PARAESTHESIA
8%
Abdominal pain upper
8%
NASOPHARYNGITIS
8%
OEDEMA PERIPHERAL
7%
Muscle spasms
7%
Nail disorder
7%
Nail discolouration
7%
RADIATION SKIN INJURY
7%
PRURITUS
7%
HYPOKALAEMIA
6%
ABDOMINAL PAIN UPPER
6%
Back pain
6%
Dyspnoea
6%
Dermatitis
6%
Abdominal pain
6%
Urinary tract infection
6%
Weight decreased
6%
Hypertension
6%
PAIN IN EXTREMITY
6%
NAIL DISCOLOURATION
6%
Lacrimation increased
6%
Oropharyngeal pain
6%
Erythema
6%
Malaise
6%
NAIL DISORDER
6%
EJECTION FRACTION DECREASED
5%
Rhinitis
5%
Musculoskeletal pain
5%
Cystitis
5%
Breast pain
5%
Onycholysis
5%
Rhinorrhoea
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
URINARY TRACT INFECTION
5%
WEIGHT DECREASED
5%
Paronychia
5%
MALAISE
5%
Bone pain
5%
Oedema
5%
ERYTHEMA
5%
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
5%
ABDOMINAL PAIN
5%
LACRIMATION INCREASED
4%
DYSPNOEA
4%
RHINORRHOEA
4%
Haemorrhoids
4%
Influenza like illness
4%
Dry eye
4%
HAEMORRHOIDS
4%
DERMATITIS
4%
Febrile neutropenia
4%
FEBRILE NEUTROPENIA
4%
BACK PAIN
4%
BONE PAIN
3%
Anxiety
3%
DRY EYE
2%
PARONYCHIA
2%
Gastritis
2%
Cardiac failure
1%
Pneumonia
1%
Injection site reaction
1%
Mastitis
1%
INJECTION SITE REACTION
1%
Postoperative wound infection
1%
Sepsis
1%
SEPSIS
1%
POSTOPERATIVE WOUND INFECTION
1%
CARDIAC FAILURE
1%
MASTITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (hormone therapy, radiation therapy, apalutamide)Experimental Treatment5 Interventions
Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (hormone therapy, radiation therapy)Active Control4 Interventions
Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Apalutamide
2015
Completed Phase 2
~5710
Hormone Therapy
2018
Completed Phase 3
~550
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
237 Previous Clinical Trials
102,189 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,013,882 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Ronald C ChenPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
834 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using a 5-alpha reductase inhibitor but can stop if needed.My PSA levels are detectable after prostate surgery.I have been mostly active and able to carry out all my pre-disease activities up to 90 days before signing up.My recent PET scan shows no distant spread of cancer.I have been diagnosed with prostate cancer and had surgery to remove it.My cancer stage, according to AJCC 8th edition, qualifies.My prostate cancer has spread only to lymph nodes in my pelvis.I started hormone therapy for prostate cancer less than 6 months ago and stopped any oral antiandrogen before registering.My kidney function, measured by creatinine clearance, is adequate.I stopped taking medications that can increase my risk of seizures 30 days ago.I am HIV positive, on treatment, with an undetectable viral load and CD4 count >= 200.My hepatitis B virus load is undetectable with treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus recently.I have had cancer before, but it won't affect this trial's treatment.My scans show cancer has spread to distant parts of my body.I have had chemotherapy for this cancer before, but treatments for other cancers were over 3 years ago.I've had radiation in the same area where my current cancer is located.I have received hormone therapy before prostate surgery.I have stopped any androgen receptor inhibitor treatments at least 180 days before enrolling.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (hormone therapy, radiation therapy, apalutamide)
- Group 2: Arm I (hormone therapy, radiation therapy)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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