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Apalutamide, Radiotherapy and LHRH Agonist in High-Risk Hormone-Sensitive Prostate Cancer Patients Assessed by PSMA-PET
EU CTIS ID: 2023-505852-23-00
What this study is testing
To determine if the addition of apalutamide to RT+LHRHa delays metastatic progression as assessed by PSMA-PET or death compared with RT+LHRHa alone.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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 at least one loco-regional (pelvic) lesion with distant extra-pelvic lesion(s)
- 8. Criterion changed per Amendment 1. 8.1 Criterion changed per Amendment 2. 8.2 Criterion changed per Amendment 3 8.3 Patients with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, 99m Tc whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the patient should be excluded from the study. Conventional images (99mTc bone scan and CT/MRI) from screening will be evaluated locally before randomization.
- 9. Eastern Cooperative Oncology Group Performance Status Grade 0 or 1.
What rules you out
- 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 exclusionary.
- 8. Use of 5-alpha-reductase inhibitor ≤4 weeks prior to randomization.
- 9. Use of investigational agent ≤4 weeks prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon
- United States
- Australia
- Russian Federation
- Mexico
- Jordan
- Turkey
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon; United States; Australia; Russian Federation; Mexico; Jordan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.