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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7.5 years
Awards & highlights
INNOVATE 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.Check my eligibility
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.See study design
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.
INNOVATE Trial 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.
INNOVATE Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metastasis-free survival (MFS)
Secondary outcome measures
Biochemical progression-free survival (bPFS)
Cancer-specific survival
Incidence of adverse events
+4 moreOther outcome measures
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 • NCT0349385470%
ALOPECIA
60%
NAUSEA
55%
DIARRHOEA
41%
ANAEMIA
30%
ASTHENIA
24%
STOMATITIS
24%
NEUTROPENIA
22%
FATIGUE
21%
CONSTIPATION
20%
HEADACHE
19%
ALANINE AMINOTRANSFERASE INCREASED
19%
MUCOSAL INFLAMMATION
19%
NEUTROPHIL COUNT DECREASED
18%
VOMITING
18%
DECREASED APPETITE
18%
ARTHRALGIA
17%
RASH
17%
MYALGIA
15%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
PYREXIA
14%
DYSGEUSIA
13%
INFUSION RELATED REACTION
13%
PERIPHERAL SENSORY NEUROPATHY
13%
EPISTAXIS
13%
LEUKOPENIA
12%
NEUROPATHY PERIPHERAL
12%
WHITE BLOOD CELL COUNT DECREASED
12%
COUGH
12%
DRY SKIN
11%
INSOMNIA
10%
HOT FLUSH
10%
DYSPEPSIA
9%
UPPER RESPIRATORY TRACT INFECTION
9%
PROCEDURAL PAIN
9%
DIZZINESS
8%
OEDEMA PERIPHERAL
8%
NASOPHARYNGITIS
8%
PARAESTHESIA
7%
PRURITUS
7%
RADIATION SKIN INJURY
7%
HYPOKALAEMIA
6%
NAIL DISCOLOURATION
6%
NAIL DISORDER
6%
ABDOMINAL PAIN UPPER
6%
EJECTION FRACTION DECREASED
6%
PAIN IN EXTREMITY
5%
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
5%
MALAISE
5%
ABDOMINAL PAIN
5%
URINARY TRACT INFECTION
5%
WEIGHT DECREASED
5%
LACRIMATION INCREASED
5%
ERYTHEMA
4%
HAEMORRHOIDS
4%
BACK PAIN
4%
BONE PAIN
4%
DYSPNOEA
4%
RHINORRHOEA
4%
DERMATITIS
4%
FEBRILE NEUTROPENIA
3%
DRY EYE
2%
PARONYCHIA
1%
SEPSIS
1%
MASTITIS
1%
POSTOPERATIVE WOUND INFECTION
1%
INJECTION SITE REACTION
1%
CARDIAC FAILURE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
INNOVATE 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
Hormone Therapy
2018
Completed Phase 3
~550
Radiation Therapy
2017
Completed Phase 3
~7250
Apalutamide
2015
Completed Phase 2
~3310
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,266 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,268 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 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:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions can Hormone Therapy alleviate?
"Hormone Therapy is often used to improve the condition of the scalp. It can also be taken as a medication for thyroiditis, prostate cancer non-metastatic, and ulcerative colitis."
Answered by AI
Is this clinical trial being conducted at a few research centers or many across the country?
"Currently, this study is taking place in 100 research centres. If you are considering enrolling, please note that locations include Kansas City, Cape Girardeau, Chicago and other nearby cities. It may be convenient for you to select the site closest to your location."
Answered by AI
Could you provide the total number of people who have signed up for this clinical trial?
"That is correct. If you visit clinicaltrials.gov, you'll see that the most recent update to this trial was on 8/11/2022. They are looking for 586 individuals who meet the criteria to participate at 100 different locations."
Answered by AI
Does this research build on existing literature about Hormone Therapy?
"There are currently 475 ongoing studies related to Hormone Therapy, with 132 of them being Phase 3 trials. Some of the California-based research for Hormone Therapy is running out of Duarte; however, there are a total of 19933 locations conducting research on this topic."
Answered by AI
Is Hormone Therapy recognized by the FDA as a reliable treatment?
"Hormone Therapy received a safety score of 3 because there is both some efficacy data and multiple rounds of supportive safety data."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
What portion of applicants met pre-screening criteria?
Did not meet criteria
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