Apalutamide, Radiotherapy and LHRH Agonist in High-Risk Hormone-Sensitive ProstateCancer Patients Assessed by PSMA-PET
- Conditions
- High risk recurrent prostate cancer previously treated with radical prostatectomyMedDRA version: 21.0Level: PTClassification code: 10036911Term: Prostate cancer recurrent Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505852-23-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 452
1. Person, 18 years of age or older (or the legal age of consent in the jurisdiction in which the study is taking place)., 10. Criterion changed per Amendment 1. 10.1 Adequate organ function as defined by the following criteria: - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 X upper limit of normal (ULN) and total bilirubin =1.5 x ULN. - Serum creatinine <1.8 mg/dL. - Platelets =75,000/µL, without transfusion or growth factors within 1 month prior to randomization. - Hemoglobin =10.0 g/dL (6.21 mmol/L), without transfusion or growth factors within 1 month prior to randomization., 11. Criterion changed per Amendment 1. 11.1 Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce., 12. Criterion changed per Amendment 1. 12.1 If the participant engages in sexual activity with a person of childbearing potential, a condom must be used together with another highly effective method of contraception during the Treatment Period and for 3 months after the last dose of study drug., 13. The participant must agree not to donate sperm for the purpose of reproduction during the Treatment Phase and for a minimum 3 months after receiving the last dose of study drug., 14. Criterion added per Amendment 1. Participants receiving bone-loss prevention treatment with bone-sparing agents indicated for the treatment of osteoporosis at doses and dosing schedules appropriate for the treatment of osteoporosis (eg, denosumab [Prolia®], zoledronic acid [Reclast®]) must be on stable doses for at least 4 weeks before randomization., 15.Criterion added per Amendment 2. Participant is indicated and planned to receive whole pelvic SRT for BCR prostate cancer., 2. Signed an Informed Consent Form (ICF) indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study; participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol., 3. Histologically confirmed adenocarcinoma of the prostate., 4.1 Criterion changed per Amendment 2. 4.2 Criterion changed per Amendment 3 4.3 Previously treated with radical prostatectomy with or without lymph node dissection and either a)For Biochemical recurrence after RP: Any post-operative PSA measurement of <0.1 ng/mL within 12 months after RP and without any PSA =0.1 ng/mL within the 4 to 8-week period after RP. OR b)For persistent PSA after RP: PSA =0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later., 5. Criterion deleted per Amendment 2, 6. Criterion changed per Amendment 1. 6.1 Criterion changed per Amendment 2. 6.2 Criterion changed per Amendment 3 6.3 High risk of developing metastasis defined as: a) For biochemical recurrence after RP: pathological Gleason score =8, evaluated from prostate tissue specimen at radical prostatectomy, OR PSADT =12 months at the time of screening. b) For persistent PSA after RP: Pathological Gleason score =8, evaluated from prostate tissue specimen at radical prostatectomy, 7. Criterion changed per Amendment 1. 7.1 Criterion changed per Amendment 3 7.2 Results of PSMA-PET at screening , as determined by BICR, must be: - PSMA-PET-negative for any prostate cancer lesions (ie, no locoregional lesion and no distant lesions); OR - PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra pelvic lesion OR - PSMA-PET-positive for
1. History of pelvic radiation for malignancy., 10. Not applicable; criterion numbering omitted from initial protocol in error., 11. Prior chemotherapy for prostate cancer., 12. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: - Non-muscle invasive bladder cancer. - Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. - Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and considered to have a very low risk of recurrence. - Malignancy that is considered cured with minimal risk of recurrence., 13. Human immunodeficiency virus-positive participants with 1 or more of the following: - Not receiving highly active antiretroviral therapy - Had a change in antiretroviral therapy within 6 months of the start of screening - Receiving antiretroviral therapy that may interfere with study treatment (consult Sponsor for review of medication prior to enrollment) - CD4 count <350 at screening - AIDS-defining opportunistic infection within 6 months of start of screening, 14. Chronic, active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction., 15. History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness =1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)., 16. Treatment with drugs known to lower the seizure threshold within 4 weeks prior to randomization., 17. Known or suspected contraindications or hypersensitivity to apalutamide, LHRH agonist or any of the components of the formulations., 18. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant., 19. Criterion deleted per Amendment 1., 2. Criterion deleted per Amendment 1., 20.Criterion added per Amendment 2. Any evidence of prostate cancer metastasis on CT/MRI of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening., 3. Previous treatment with ADT for prostate cancer., 4. Criterion changed per Amendment 2. 4.1 Previously treated for BCR or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)., 5. Prior treatment with a CYP17 inhibitor (eg, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any AR antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (eg. estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy., 6. Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate., 7. Any of the following within 6 months prior to firial infarction, symptomatist dose of study treatment: severe or unstable angina, myocardc congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusiona
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method