2022-08-04
minor
Study Status, Study Description, Arms and Interventions, Eligibility v6
Eligibility criteria-32 characters
[...] eeks.
Attempts must be made to wean patients off prednisone and be off therapy for ≥ 1 week prior to starting therapy.
Patients who cannot be weaned due [...]
Study description+467 characters
[...] or at least one cycle.
Each cycle is 56 days.
Patients with PSA progression (≥25% increase in PSA from baseline PSA on BAT cycle) will stop T injection and begin Enzalutamide.
Patients on T with initial with declining PSA decline PSA will remain on high dose T for additional cycles of 2 injections until PSA progression occurs (≥25% increase in PSA from PSA nadir on current BAT cycle)based on PCWG3 criteria.
Patients with PSA progression (≥25% [...] ction.
These patients will then be started on Enzalutamide.
Patients with PSA progression (≥25% increase in PSA from baseline on enzalutamide cycle) will [...] [...]
2021-02-03
notable
Active, Not Recruiting→Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v3
Trial statusActive, Not Recruiting→Recruiting
Enrollment target90→150
Study arms2→3
Eligibility criteria-17 characters
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.
Age ≥18 years.
Histologically-confir [...] CT or bone scan.
Must have had disease progression while on abirateronecombination acetate alone orof abiraterone acetate in combination with otherplus ADT. either given concurrently or sequentially based on:
PSA progression defined as an increase in PSA, as determin [...] tamide, apalutamide, darolutamide, or other investigational androgen receptor (AR) targeted treatment is allowed.
Prior treatment with testosterone is allowed.
Prior treatment with one chemotherapy regimen with d [...] [...]
Study description+1,009 characters
[...] sistance to primary ADT.
Patients will continue on ADT with Luteinizing hormone-releasing hormone (LHRH) agonist (i.e.
Zoladex, Trelstar, Eligard or Lupron) or LHRH [...] enous testosterone production.
Patients will be randomized 1:2:2 and stratified based on whether patientsthey received Abi in combination with ADT or in sequence after p [...] e (2 injections) with one cycle of 56 days of enzalutamide.
Patients randomized to Arm C will receive Variable Sequential Testosterone and Enzalutamide (VSTE).
Patients in Arm C will receive intramuscular injection with testosterone cypionate (T) at an FDA-approved d [...] [...]
Study sitesdetails revised at 1 of 1 site
2020-08-31
notable
Not Yet Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v2
Trial statusNot Yet Recruiting→Active, Not Recruiting
Start dateestimated 2020-10→confirmed 2020-08-19