Prostate Cancer With OligometaSTatic Relapse: Combining Stereotactic Ablative Radiotherapy and Durvalumab (MEDI4736)

Sponsor
Institut Cancerologie de l'Ouest
Study ID
NCT03795207
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Bone Metastases
  • Node; Prostate
  • Prostate Cancer Patients

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SBRT + Durvalumab — COMBINATION_PRODUCT
    Durvalumab, MEDI4736, is a immunotherapy, SBRT (stereotactic body radiotherapy) is a procedure that uses high doses of radiation delivered to a precise target. By using special positioning and implanted markers in the body, radiologists are able to deliver a much higher dose of radiation to a cancer than traditional radiation therapy
  • SBRT — RADIATION
    SBRT (stereotactic body radiotherapy) is a procedure that uses high doses of radiation delivered to a precise target. By using special positioning and implanted markers in the body, radiologists are able to deliver a much higher dose of radiation to a cancer than traditional radiation therapy

Study Details

As in other solid tumours, increasing evidence indicates that patients diagnosed with a limited number of prostate cancer metastases, so-called oligometastases, have a better prognosis compared with patients with extensive metastatic disease. Survival of patients with three or fewer metastases was superior compared with patients with more than three lesions. The introduction of novel imaging modalities such as Fluorocholine (FCH), Fuciclovine or Ga-PSMA PET CT has increased the detection of oligometastatic prostate cancer (PCa) recurrence, potentially justifying the use of a metastasis-directed therapy with radiotherapy (RT). Based on several studies, SBRT is now considered as a strongly validated option in oligometastatic prostate cancer. It is increasingly understood that cancers are recognized by the immune system, and, under some circumstances, the immune system may control or even eliminate tumors. Programmed death-ligand 1 (PD-L1) is transmembrane protein that has been speculated to play a major role in suppressing the immune system during particular events. PD-L1 is expressed in a broad range of cancers. Based on these findings, an anti-PD-L1 antibody could be used therapeutically to enhance antitumor immune responses in patients with cancer. Experimental data from multiple cancer models have provided cumulative evidence of an interaction of ionizing radiation with the systemic antitumor immunity and this has created several opportunities in the field. The oligometastatic setting appears to be the most relevant clinical situation to evaluate the immune response generated by radiotherapy and immune modifiers in patients with an intact immune system. The hypothesize is that Durvalumab will enhance immune response following SBRT targeting oligometastatic lesions. In this randomized 2:1 phase II trial of Stereotactic Body Radiation Therapy with or without durvalumab in oligometastatic hormone sensitive prostate cancer patients, Durvalumab will be started one month prior to SBRT to be able to evaluate PSA and immune response to the drug. It will be combined with SBRT and then given adjuvantly for a total of 12 months.

Key Dates

Start date
Mar 21, 2019
Status verified
Mar 2026
Primary completion
Dec 27, 2023
Completion
Dec 27, 2027

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm SBRT + DURVALUMAB
    Radiation (SBRT) + Immunotherapy treatment (Durvalumab) 64 patients will be enrolled in this arm Durvalumab, will be started one month prior to SBRT and then given for a total of 12 months. Patient will receive one injection per months (1500 mg/cycle) SBRT will be started one month after Durvalumab and patients will receive 3 fractions of radiation
  • Active Comparator: Arm SBRT
    Radiation (SBRT) 32 patients will be enrolled in this arm Patients will receive only 3 fractions of radiation

Primary Outcome Measure

Two-years Progression-free survival [ Time Frame: 54 months ]

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