A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prostate Cancer Participants
- Conditions
- Prostatic NeoplasmsProstatic Neoplasms, Genital Neoplasms, Male Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Prostatic DiseasesD40.0
- Registration Number
- LBCTR2020124661
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 20
1- Histologically confirmed adenocarcinoma of the prostate
2- Previously treated with radical prostatectomy with lymph node dissection and first postoperative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) between Week 6 and Week 13
3- Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
4- Prostate-specific membrane antigen-positron emission tomography (PSMA-PET) must be performed at screening: Patients who are PSMA-PET-positive for at least one loco-regional (pelvic) lesion with or without distant (extra-pelvic) lesions at screening, as determined by Blinded Independent Central Review (BICR), will be eligible to be randomized to either arm of the Interventional Cohort. The investigators will be blinded to the location of the PSMA-PET lesions after randomization and patients who are PSMA-PET-negative for any prostate cancer lesions (that is no loco-regional lesion and no distant lesion) at screening, as determined by BICR, will be eligible for inclusion in the Observational Cohort
5- Biochemically recurrent prostate cancer after RP with a high risk of developing metastasis defined as pathological Gleason score greater than or equal to (=) 8 at diagnosis or time of surgery, OR PSADT less than or equal to (=) 12 months at the time of screening using at least 3 consecutive values =0.1 nanograms per milliliter (ng/mL), from time of BCR, estimated using the Memorial Sloan Kettering Cancer Center online calculator
6- No evidence of metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m [99mTc] 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 the screening will be sent to BICR for confirmation of metastatic disease before randomization
7- Eastern Cooperative Oncology Group Performance Status Grade 0 or 1
1- History of pelvic radiation for malignancy
2- Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
3- Previously treated for biochemical recurrence (BCR) prostate cancer
Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
4- Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
5- Prior chemotherapy for prostate cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS);Timepoints: Up to 7 years;Measure: ppMPFS is defined as the appearance of at least 1 new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death
- Secondary Outcome Measures
Name Time Method