Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: OMCT: Cyclophosphamide 50 100 mg OD (3 weeks on/1 week off) + Dexamethasone 0.5 mg BD,
oral.
Control Intervention1: PCT: Any standard-of-care therapy as per physician s choice
Sponsors
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Men greater than 18 years of age with histologically or cytologically confirmed adenocarcinoma of the prostate. Prior treatment with one novel hormonal therapy such as abiraterone apalutamide darolutamide or enzalutamide for castration sensitive locally advanced disease stage T3 or T4 or metastatic castration sensitive prostate cancer or non metastatic castration resistant prostate cancer or metastatic castration resistant prostate cancer. Patients who are not fit for such therapy for any reason as judged by the treating physician may also be included. Prior treatment with docetaxel. Patients who are not fit for or not willing to receive intravenous chemotherapy may also be included. Surgical or medical castration with serum testosterone at or below fifty nanograms per deciliter at screening. Serum testosterone assessment is required for patients on medical castration. Presence of measurable extrapelvic soft tissue metastatic disease as assessed by the investigator defined by at least one of the following. Measurable visceral disease involving organs such as adrenal kidney liver lung pancreas or spleen as per RECIST version one point one. Or measurable extrapelvic lymphadenopathy above the level of aortic bifurcation. Confirmed progressive disease at study entry demonstrated by at least one of the following. a. PSA progression defined as at least two consecutive rises in PSA measured at least one week apart with a minimum starting PSA level of two nanograms per milliliter and confirmation by a third measurement showing continued increase. b. Radiographic progression defined as progressive soft tissue disease on computed tomography scan or PSMA PET CT scan as per RECIST version one point one. For bone disease at least two new bone lesions on follow up imaging. If progression is observed within twelve weeks of treatment start a confirmatory scan must show at least two additional new lesions. If progression is observed after twelve weeks confirmation is required without the need for additional lesions. Eastern Cooperative Oncology Group performance status of zero to two. Recovery to baseline or grade one or lower toxicity as per Common Terminology Criteria for Adverse Events version five from prior treatments unless the adverse events are clinically non significant or stable on supportive therapy as judged by the investigator. Adequate liver and bone marrow function based on laboratory assessments performed within twenty eight days prior to randomization including total bilirubin less than two point five times the upper limit of normal aspartate aminotransferase and alanine aminotransferase less than five times the upper limit of normal hemoglobin eight grams per deciliter or higher platelet count greater than seventy five thousand per cubic millimeter and absolute neutrophil count greater than one thousand five hundred per cubic millimeter. Ability to understand and comply with protocol requirements. Ability to understand and willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Known brain metastases or cranial epidural disease unless adequately treated and clinically stable prior to randomization. Symptomatic or impending spinal cord compression or cauda equina syndrome unless adequately treated and clinically stable prior to randomization. Presence of uncontrolled significant intercurrent or recent illness that may interfere with study participation or safety. History of major surgery within four weeks prior to randomization. Inability or unwillingness to swallow oral medications or receive intravenous administration as required by the study. Previously identified allergy or hypersensitivity to any component of the study treatment formulations or a history of severe infusion related reactions to monoclonal antibodies. Presence of any other active malignancy at the time of randomization or diagnosis of another malignancy within two years prior to randomization that requires active treatment. Exceptions may apply for locally curable malignancies that have been adequately treated and are considered cured.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To compare the overall survival of OMCT with PCT for mCRPCTimepoint: Approximately 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: 1. To compare the progression-free survival of OMCT with PCT for mCRPC 2. To compare the quality of life (QOL)and Patient Reported Outcomes (PROs) as determined by EORTC QLQ PR 25 questionnaire for patients receiving OMCT versus PCT 3. To assess compliance to medication in the two arms 4. To evaluate the difference in the total expenditure of the patient in the two arms Exploratory Objectives 1. If feasible, HRR testing & other suitable molecular testing will be performed to compare the outcomes & response to the treatment. Performance of HRR testing will depend on availability of funding for the same. HRR testing will not be mandatory for the purpose of inclusion in the study/ conduct of the study. Timepoint: QoL assessments will be done at the following time-points: -Baseline -Every 3 months at every planned follow-up visit -End-of-Treatment Other secondary objectives will be assessed at approximately 4 years. | — |
Countries
India
Contacts
Public ContactDr Akhil Kapoor
Mahamana Pandit Madanmohan Malviya Cancer Centre (MPMMCC)
Outcome results
None listed