Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/13/2019 |
Start Date: | April 27, 2018 |
End Date: | October 31, 2028 |
Contact: | Daniel Spratt, MD |
Email: | sprattda@med.umich.edu |
Phone: | 734-232-5244 |
A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer
This phase II trial studies how well radiation therapy with or without apalutamide works in
treating patients with stage III-IV prostate cancer. Radiation therapy uses high energy x-ray
to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer
cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving
radiation therapy and apalutamide may work better at treating prostate cancer than radiation
alone.
treating patients with stage III-IV prostate cancer. Radiation therapy uses high energy x-ray
to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer
cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving
radiation therapy and apalutamide may work better at treating prostate cancer than radiation
alone.
PRIMARY OBJECTIVES:
I. To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation
(SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical
progression-free survival (bPFS) compared to SRT alone.
SECONDARY OBJECTIVES:
I. To assess whether molecular stratification by the PAM50 gene expression clustering will
identify subsets of prostate cancer (luminal A or basal, luminal B) which derive the greatest
benefit from anti-androgen therapy.
II. To assess overall survival. III. To assess cancer-specific mortality. IV. To assess
metastasis-free survival. V. To assess distant metastasis. VI. To assess local-regional
progression. VII. To assess PSA nadir during first year of treatment and prior to initiation
of any hormonal salvage therapy.
VIII. To assess initiation of salvage hormonal therapy. IX. To assess PSA with a non-castrate
testosterone at 1 and 3 years post randomization: PSA < 0.1 ng/ml and testosterone >= 50
ng/dl.
X. To assess acute and late physician-reported morbidity (per the Common Terminology Criteria
for Adverse Events [CTCAE] version 5) after SRT +/- apalutamide.
XI. To assess acute and late patient-reported morbidity (per the patient reported outcomes
[PRO]-CTCAE) after SRT +/- apalutamide.
XII. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on
Day 1 of radiation therapy, patients receive placebo orally (PO) once daily (QD) on days
1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of
disease progression or unacceptable toxicity.
ARM 2: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on
Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment
repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
then every 6 months for 3 years, and then yearly thereafter.
I. To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation
(SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical
progression-free survival (bPFS) compared to SRT alone.
SECONDARY OBJECTIVES:
I. To assess whether molecular stratification by the PAM50 gene expression clustering will
identify subsets of prostate cancer (luminal A or basal, luminal B) which derive the greatest
benefit from anti-androgen therapy.
II. To assess overall survival. III. To assess cancer-specific mortality. IV. To assess
metastasis-free survival. V. To assess distant metastasis. VI. To assess local-regional
progression. VII. To assess PSA nadir during first year of treatment and prior to initiation
of any hormonal salvage therapy.
VIII. To assess initiation of salvage hormonal therapy. IX. To assess PSA with a non-castrate
testosterone at 1 and 3 years post randomization: PSA < 0.1 ng/ml and testosterone >= 50
ng/dl.
X. To assess acute and late physician-reported morbidity (per the Common Terminology Criteria
for Adverse Events [CTCAE] version 5) after SRT +/- apalutamide.
XI. To assess acute and late patient-reported morbidity (per the patient reported outcomes
[PRO]-CTCAE) after SRT +/- apalutamide.
XII. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on
Day 1 of radiation therapy, patients receive placebo orally (PO) once daily (QD) on days
1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of
disease progression or unacceptable toxicity.
ARM 2: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on
Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment
repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
then every 6 months for 3 years, and then yearly thereafter.
Inclusion Criteria:
- Pathologically (histologically) proven diagnosis of prostate adenocarcinoma;
prostatectomy must have been performed within 10 years prior to Step 1 registration
and any type of radical prostatectomy is permitted, including retropubic, perineal,
laparoscopic or robotically assisted
- Post-prostatectomy patients with a detectable serum PSA (≥ 0.1, but ≤ 1.0 ng/mL) at
study entry (within 90 days of Step 1 registration) and at least one of the following:
- Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade
group 2 to 5)
- ISUP grade group:
- Grade Group 1: Gleason score ≤ 6,
- Grade Group 2: Gleason score 3 + 4 = 7,
- Grade Group 3: Gleason score 4 + 3 = 7,
- Grade Group 4: Gleason score 8,
- Grade Group 5: Gleason scores 9 and 10
- >= T3a disease
- Persistent elevation of PSA after prostatectomy measured within 90 days after
surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)
- pN0 or pNx
- History/physical examination within 90 days prior to Step 1 registration
- Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
- Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for
submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if
Decipher results have already been obtained, in lieu of tissue, results must be
submitted to GenomeDx for validation
- Prior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH]
agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90
days prior to Step 1 registration and given for ≤ 90 days duration
- For example: patients on prior LHRH analogs (post-prostatectomy), the
discontinuation date should be calculated based on the expected duration of the
sustained release injection, not simply the injection date of the drug; for
instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3
month duration), then the expected duration of such a dose would be 90 days after
the injection date; for a 7.5 mg leuprolide (1 month duration), the
discontinuation date would be 30 days after the injection date
- Please note: finasteride or dutasteride must be stopped before treatment starts
but prior usage will not affect eligibility
- Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days
prior to Step 1 registration
- Platelet count ≥ 100,000 x 10^9/uL independent of transfusion and/or growth factors
within 90 days prior to step 1 registration
- Serum albumin ≥ 3.0 g/dL within 90 days prior to Step 1 registration
- Glomerular filtration rate (GFR) ≥ 35 mL/min estimated by Cockcroft-Gault or measured
directly by 24 hour urine creatinine within 90 days prior to Step 1 registration
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (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) within 90 days
prior to Step 1 registration
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN within
90 days prior to Step 1 registration
- Testosterone > 50 ng/dL within 90 days prior to Step 1 registration
- Concomitant medications known to lower the seizure threshold discontinued or
substituted at least 4 weeks (30 days) prior to Step 1 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
- The patient must agree not to donate sperm during the study treatment and for 3 months
after receiving the last dose of study drug
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry
Exclusion Criteria:
- Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or
lymph node involvement (N1)
- Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of
the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely
resected melanoma) unless disease free for a minimum of 2 years
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- 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 Step 1 registration)
- History of documented inflammatory bowel disease
- Transmural myocardial infarction within the last 4 months prior to Step 1
registration.
- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months prior to Step 1 registration
- History of any condition that in the opinion of the investigator, would preclude
participation in this study
- Current evidence of any of the following:
- Known gastrointestinal disorder affecting absorption of oral medications
- Active uncontrolled infection (eg, human immunodeficiency virus [HIV] or viral
hepatitis)
- Uncontrolled hypertension
- Any current condition that in the opinion of the investigator, would preclude
participation in this study
- Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused
ultrasound [HIFU]) for prostate cancer is not allowed
- HIV positive with CD4 count < 200 cells/microliter within 30 days prior to
registration
- HIV patients under treatment with highly active antiretroviral therapy (HAART) within
30 days prior to registration regardless of CD4 count. (Note: HIV testing is not
required for eligibility for this protocol as it is self-reported.)
- For patients who have not undergone prior Decipher analysis, submission of the
specimen to GenomeDx should be as soon as possible after study registration (Step 1)
as these results can take up 21 days after the specimen is received at GenomeDx; Step
2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher
results have already been obtained, in lieu of tissue, results must be submitted to
GenomeDx for validation
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(937) 734-2612
![Good Samaritan Hospital - Dayton](/wp-content/uploads/logos/good-samaritan-hospital---dayton.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-832-1093
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2300 N Edward St
Decatur, Illinois 62526
Decatur, Illinois 62526
(217) 876-8121
![Decatur Memorial Hospital](/wp-content/uploads/logos/decatur-memorial-hospital.jpg)
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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1111 6th Ave
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
![Mercy Medical Center - Des Moines](/wp-content/uploads/logos/mercy-medical-center---des-moines.jpg)
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
Mercy Medical Center - Des Moines Mercy Medical Center
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Des Moines, Iowa 50314
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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East Lansing, Michigan 48824
Principal Investigator: Jatin Rana
Phone: 517-975-9547
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6401 France Ave S
Edina, Minnesota 55435
Edina, Minnesota 55435
(952) 924-5000
![Fairview Southdale Hospital](/wp-content/uploads/logos/fairview-southdale-hospital.gif)
Principal Investigator: Paul W. Sperduto
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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1900 S Main St
Findlay, Ohio 45840
Findlay, Ohio 45840
(419) 423-4500
![Blanchard Valley Hospital](/wp-content/uploads/logos/blanchard-valley-hospital.jpg)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
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Findlay, Ohio 45840
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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1024 S Lemay Ave
Fort Collins, Colorado 80524
Fort Collins, Colorado 80524
(970) 495-7000
![Poudre Valley Hospital](/wp-content/uploads/logos/poudre-valley-hospital.jpg)
Principal Investigator: Brandon D. Bernard
Phone: 970-297-6150
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Fort Collins, Colorado 80528
Principal Investigator: Brandon D. Bernard
Phone: 412-339-5294
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Fort Wayne, Indiana 46805
Principal Investigator: Brian K. Chang
Phone: 260-373-8888
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Fort Wayne, Indiana 46845
Principal Investigator: Brian K. Chang
Phone: 877-784-4673
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One Medical Center Drive
Franklin, Ohio 45005
Franklin, Ohio 45005
(513) 424-2111
![Atrium Medical Center - Middletown Regional Hospital](/wp-content/uploads/logos/atrium-medical-center---middletown-regional-hospital.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Atrium Medical Center - Middletown Regional Hospital Atrium Medical Center (Atrium) is built on the...
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Franklin, Ohio 45005
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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550 Osborne Rd NE
Fridley, Minnesota 55432
Fridley, Minnesota 55432
(763) 236-5000
![Unity Hospital](/wp-content/uploads/logos/unity-hospital.jpg)
Principal Investigator: Paul W. Sperduto
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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Gilbert, Arizona 85297
Principal Investigator: Jason M. Samuelian
Phone: 480-922-4600
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Glenwood Springs, Colorado 81601
Principal Investigator: Peter J. Rossi
Phone: 970-384-7570
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Goshen, Indiana 46526
Principal Investigator: James A. Wheeler
Phone: 574-364-2973
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Grafton, Wisconsin 53024
Principal Investigator: Ellen L. Ziaja
Phone: 414-302-2304
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Grand Rapids, Michigan 49503
Principal Investigator: Kathleen J. Yost
Phone: 412-339-5294
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100 Michigan St NE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 391-1774
![Spectrum Health Butterworth Hospital](/wp-content/uploads/logos/spectrum-health-at-butterworth-campus.jpg)
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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1117 29th St S
Great Falls, Montana 59405
Great Falls, Montana 59405
(406) 771-7300
![Benefis Healthcare- Sletten Cancer Institute](/wp-content/uploads/logos/benefis-healthcare--sletten-cancer-institute.gif)
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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1900 16th Street
Greeley, Colorado 80631
Greeley, Colorado 80631
Principal Investigator: Brandon D. Bernard
Phone: 412-339-5294
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
(920) 288-8000
![Aurora BayCare Medical Center](/wp-content/uploads/logos/aurora-baycare-medical-center.jpg)
Principal Investigator: Ellen L. Ziaja
Phone: 414-302-2304
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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Greenbrae, California 94904
Principal Investigator: Lloyd T. Miyawaki
Phone: 415-925-7325
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835 Sweitzer St
Greenville, Ohio 45331
Greenville, Ohio 45331
(937) 548-1141
![Wayne Hospital](/wp-content/uploads/logos/wayne-hospital.jpg)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
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Greenville, Ohio 45331
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Greenville, South Carolina 29605
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Greenville, South Carolina 29615
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Greenwood, South Carolina 29646
Principal Investigator: David T. Marshall
Phone: 864-725-4771
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Greer, South Carolina 29650
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Henderson, Nevada 89052
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Henderson, Nevada 89074
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Henderson, Nevada 89074
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Henderson, Nevada 89052
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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2460 West Horizon Ridge Parkway
Henderson, Nevada 89052
Henderson, Nevada 89052
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Henderson, Nevada 89052
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Jefferson City, Missouri 65109
Principal Investigator: Bryan A. Faller
Phone: 573-632-4814
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Kansas City, Kansas 66160
Principal Investigator: Xinglei Shen
Phone: 913-945-7552
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Kansas City, Missouri 64154
Principal Investigator: Xinglei Shen
Phone: 913-945-7552
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Kenosha, Wisconsin 53142
Principal Investigator: Ellen L. Ziaja
Phone: 414-302-2304
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Kettering, Ohio 45409
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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3535 Southern Blvd
Kettering, Ohio 45429
Kettering, Ohio 45429
(937) 298-4331
![Kettering Medical Center](/wp-content/uploads/logos/kettering-medical-center.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Kettering, Ohio 45420
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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1215 E Michigan Ave
Lansing, Michigan 48912
Lansing, Michigan 48912
(517) 364-1000
![Sparrow Hospital](/wp-content/uploads/logos/sparrow-hospital.gif)
Principal Investigator: Samir Narayan
Phone: 734-712-3671
Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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Las Vegas, Nevada 89144
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Las Vegas, Nevada 89169
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
![Comprehensive Cancer Centers of Nevada](/wp-content/uploads/logos/comprehensive-cancer-centers-of-nevada.jpg)
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, Nevada 89182
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Las Vegas, Nevada 89148
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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