oligometastatic hormone sensitive prostate cancer MedDRA version: 20.0 Level: LLT Classification code 10007463 Term: Carcinoma prostatic System Organ Class: 100000004864
Conditions
Sponsors
INSTITUT DE CANCEROLOGIE DE L'OUEST
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 2. Age > or = 18 years at time of study entry 3. Histologically proven diagnosis of prostate cancer (PCa) 4. PCa patients with a biochemical recurrence ?following treatment with curative intent (radical prostatectomy, primary radiotherapy or a combination of both) as defined by the EAU guidelines. 5. A maximum of 5 bone or lymphnode metastases diagnosed on FCH or Ga-PSMA PET CT. 6. WHO performance state 0-1 7. Controlled primary tumor. 8. If ADT has been previously administered to the patient, a minimum of 12 months must have elapsed between the predicted duration of the last injection and inclusion of the patient in the study. For this category of patients, serum testosterone has to be higher than 6 nmol/l prior to inclusion. 9. Adequate normal organ and marrow function as defined [in protocol] 10. Body weight > 30kg 11. Life expectancy of > 24 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1. Serum testosterone level 20 Gy less than 5 years ago. 10. Previous treatment with a cytotoxic agent for PCa 11. Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids...) 13. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 14. Any prior immune therapy (CTLA-4, PD1 or PD-L1 inhibitor, including durvalumab) 15. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion: ? Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) ? Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent ? Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 16. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug 17. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Durvalumab. 19. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: ? Patients with vitiligo or alopecia ? Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement ? Any chronic skin condition that does not require systemic therapy ? Patients without active disease in the last 5 years may be included but only after consultation with the study physician ? Patients with celiac disease controlled by diet alone 20. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement 21. History of another primary malignancy except for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Two-years Progression-free survival.;Secondary Objective: a)Quality of life scoring using the EORTC QLQ-C30 supplemented with QLQ-PR25 and pain with BPI + EVA. b)Androgen deprivation therapy free survival : ADT will be started in both arms at time of polymetastatic disease, local progression of metastases (defined above) or symptoms. In case of a metachronous oligometastatic recurrence, a retreatment with radiotherapy or surgery is allowed. Calculation will start from randomization until ADT is started. c)Prostate cancer specific survival will be calculated from randomization until Prostate cancer death. d)Overall survival will be calculated from randomization until death from any cause. e)Time to first symptomatic event will be calculated from randomization until the event of symptoms due to metastatic disease. f)Acute and late toxicity due to radiotherapy will be scored using the Common toxicity criteria version 4.0. g)Sphingolipids measurements h)Immune response monitoring ;Primary end point(s): Progression : Two types of progression are defined and definitions of progression are used and registered according to the recommendations of the prostate cancer clinical trials working group. - PSA or biochemical progression - local progression : response with the iRECIST criteria - distant recurrences If a patient meets any of the progression criteria or death from any causes, the patient will be considered to have progressive disease. Calculation will start from randomization until progression or death. ;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life and pain: QLQ-C30 + QLQ-PR25 + BPI + EVA. b) Survival without anti-androgen therapy: ADT will be started in both arms at the time of polymetastatic disease, local progression of metastases (defined above) or symptoms. In the case of metachronic oligometastatic recurrence, radiotherapy or surgery may be reprocessed. The calculation will start from the inclusion randomization until the ADT is started. c) Prostate cancer-specific survival: calculated from inclusion randomization to death by prostate cancer. d) Overall survival: calculated from randomization to death of any cause e) Time to first symptoms: calculated from the inclusion of randomization until the onset of symptoms due to metastatic disease. f) Acute and late toxicity related to radiotherapy: CTC AE version 4.03 g) Determination of sphingolipids h) Monitoring the immune response;Timepoint(s) of evaluation of this end point: see above for each end point | — |
Countries
France
Contacts
Public ContactDRCI
INSTITUT DE CANCEROLOGIE DE L'OUEST
Outcome results
None listed