Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma
About this trial
This is an interventional treatment trial for Biochemically Recurrent Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria:
- STEP 0: REGISTRATION ELIGIBILITY CRITERIA
- Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
Patient must have biochemical recurrence (BCR) after RP, with rising PSA defined as follows:
- If time to biochemical recurrence, (defined as time to first detectable PSA after RP) is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (this includes patients with a persistent PSA reading of at least 0.2 ng/mL)
If time to biochemical recurrence, (defined as time to first detectable PSA after RP) is >= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
- NOTE: Qualifying PSA values per above must be collected at least 4 weeks after RP, with confirmatory persistent or elevated PSA collected at any subsequent time point
- Patient must be negative or equivocal for extrapelvic metastatic disease by conventional imaging modalities (CIM) (i.e., bone scans, pelvic CT, or pelvic MRI), which must be done within 10-12 weeks prior to registration. Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields
- Baseline PET/CT scan (PET1) are eligible for this study if the SOC PET scan using 18F-fluciclovine (Axumin) is completed during step 0 registration or up to 12 weeks prior to step 0 registration. The PET/CT scanners must meet scanner qualifications and scans must have an interpretation (or confirmation of an institutional clinical read) by a nuclear medicine physician or radiologist who has undergone 18F-fluciclovine (Axumin) reader training
- Patient must be a candidate for standard-of-care (SOC) post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (adjuvant)
- Patient must have the ability to provide written informed consent
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET/CT scan and radiation treatment planning and delivery
- Patient must be at a participating institution, which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval
- Leukocytes >= 3,000/mcL (obtained within 4 weeks prior to registration)
- Absolute neutrophil count >= 1,500/mcL (obtained within 4 weeks prior to registration)
- Platelets >= 100,000/mcL (obtained within 4 weeks prior to registration)
- Total bilirubin =< institutional upper limit of normal (ULN) (obtained within 4 weeks prior to registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 4 weeks prior to registration)
- Glomerular filtration rate (GFR) > 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine (obtained within 4 weeks prior to registration)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- 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. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
- STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
- Patient must have completed a baseline SOC PET scan (PET1) with results of extra-pelvic metastases involvement known (positive or negative)
- For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
- For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (=< 5 or > 5 pelvic lesions)
Exclusion Criteria:
- Patient must not have started androgen deprivation therapy for biochemical recurrence prior to baseline study PET/CT imaging
- Patient must not be enrolled in another therapeutic clinical trial
- Patient must not have any other malignancy within the last 2 years, other than superficial bladder cancer and skin basal cell carcinoma or cutaneous superficial squamous cell carcinoma that has not metastasized
- Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year of registration
- Patient must not have history of inflammatory bowel disease as this would increase risk of complication from radiotherapy or any gastrointestinal disorder affecting absorption
- Patient must not have had prior radiation therapy
Sites / Locations
- Anchorage Associates in Radiation MedicineRecruiting
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- Mercy Hospital Fort SmithRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- City of Hope CoronaRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- City of Hope Antelope ValleyRecruiting
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- UCLA / Jonsson Comprehensive Cancer CenterRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- City of Hope South PasadenaRecruiting
- Woodland Memorial HospitalRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Saint Francis Cancer CenterRecruiting
- Porter Adventist HospitalRecruiting
- Saint Anthony HospitalRecruiting
- Littleton Adventist HospitalRecruiting
- Longmont United HospitalRecruiting
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical CenterRecruiting
- Sibley Memorial HospitalRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Northwestern UniversityRecruiting
- University of IllinoisRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- Saint Joseph HospitalRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Jewish Hospital
- MaineHealth Coastal Cancer Treatment Center
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- Maine Medical Center-Bramhall Campus
- MaineHealth Cancer Care Center of York County
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maine Medical Center- Scarborough Campus
- Maine Medical Partners - South Portland
- University of Maryland/Greenebaum Cancer CenterRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Suburban HospitalRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Minnesota Oncology - BurnsvilleRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity Hospital
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- University of Mississippi Medical Center
- Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- CHI Health Good SamaritanRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- Cooper Hospital University Medical CenterRecruiting
- Hackensack University Medical CenterRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Robert Wood Johnson University Hospital SomersetRecruiting
- Community Medical CenterRecruiting
- MD Anderson Cancer Center at Cooper-VoorheesRecruiting
- Northwell Health Imbert Cancer CenterRecruiting
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Mount Sinai Union SquareRecruiting
- Mount Sinai ChelseaRecruiting
- Mount Sinai WestRecruiting
- Lenox Hill HospitalRecruiting
- Mount Sinai HospitalRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- Phelps Memorial Hospital CenterRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- Vidant Oncology-RichlandsRecruiting
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - CincinnatiRecruiting
- Bethesda North HospitalRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- University of Cincinnati Cancer Center-West Chester
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Legacy Mount Hood Medical Center
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Legacy Meridian Park Hospital
- UPMC AltoonaRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- Crozer-Keystone Regional Cancer Center at BroomallRecruiting
- Carlisle Regional Cancer CenterRecruiting
- Delaware County Memorial HospitalRecruiting
- Fox Chase Cancer Center - East Norriton Hospital Outpatient CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- Fox Chase Cancer Center BuckinghamRecruiting
- Crozer Regional Cancer Center at Brinton LakeRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- UPMC Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- UPMC Cancer Center-Natrona HeightsRecruiting
- UPMC Hillman Cancer Center - New CastleRecruiting
- Penn Presbyterian Medical CenterRecruiting
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University HospitalRecruiting
- Fox Chase Cancer CenterRecruiting
- Temple University HospitalRecruiting
- UPMC-Magee Womens HospitalRecruiting
- UPMC-Saint MargaretRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC-Passavant HospitalRecruiting
- UPMC-Saint Clair Hospital Cancer CenterRecruiting
- UPMC Cancer Center at UPMC NorthwestRecruiting
- UPMC Uniontown Hospital Radiation OncologyRecruiting
- UPMC Washington Hospital Radiation OncologyRecruiting
- UPMC SusquehannaRecruiting
- UPMC MemorialRecruiting
- Medical University of South CarolinaRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- UT Southwestern Simmons Cancer Center - RedBirdRecruiting
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- UT Southwestern Clinical Center at Richardson/Plano
- Audie L Murphy VA HospitalRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison Medical CenterRecruiting
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Providence Regional Cancer PartnershipRecruiting
- Swedish Cancer Institute-IssaquahRecruiting
- Providence Regional Cancer System-LaceyRecruiting
- PeaceHealth Saint John Medical CenterRecruiting
- Swedish Medical Center-Ballard CampusRecruiting
- FHCC South Lake UnionRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- Swedish Medical Center-First HillRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- PeaceHealth United General Medical CenterRecruiting
- PeaceHealth Southwest Medical CenterRecruiting
- Legacy Cancer Institute Medical Oncology and Day Treatment
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer CenterRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- UW Cancer Center Johnson CreekRecruiting
- William S Middleton VA Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Welch Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Arm A (EBRT, short-term androgen deprivation therapy [STAD])
Arm B (EBRT, STAD, apalutamide)
Arm C (EBRT, STAD, apalutamide)
Arm D (EBRT, STAD, apalutamide, RT)
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.
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.
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.
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.