NCT03795207: POSTCARD

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

Active, enrolled Phase 2 Last updated 31 March 2026

What this trial tests

Phase 2 trial testing SBRT + Durvalumab in Node; Prostate in 96 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 March 2019

Primary endpoint
27 December 2023

27 December 2027

Quick facts

Lead sponsor	Institut Cancerologie de l'Ouest
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	21 March 2019
Primary completion	27 December 2023
Estimated completion	27 December 2027
Sites	9 locations across France

Drugs / interventions tested

• SBRT + Durvalumab
• SBRT — full drug profile →

Conditions studied

• Node; Prostate — all drugs for Node; Prostate →
• Bone Metastases — all drugs for Bone Metastases →
• Prostate Cancer Patients — all drugs for Prostate Cancer Patients →

Sponsor

Institut Cancerologie de l'Ouest — full company profile →

Who can join

18 and older, male only, with Node; Prostate or Bone Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Genetic Aberrations of DNA Repair Pathways in Prostate Cancer: Translation to the Clinic.
   Ghose A, Moschetta M, Pappas-Gogos G, Sheriff M, et al · · 2021 · cited 58× · PMID 34575947 · DOI 10.3390/ijms22189783
2. Programmed death receptor (PD-)1/PD-ligand (L)1 in urological cancers : the "all-around warrior" in immunotherapy.
   Liu Q, Guan Y, Li S. · · 2024 · cited 50× · PMID 39223527 · DOI 10.1186/s12943-024-02095-8
3. Immunotherapy and radiation therapy sequencing: State of the data on timing, efficacy, and safety.
   Williamson CW, Sherer MV, Zamarin D, Sharabi AB, et al · · 2021 · cited 49× · PMID 33620731 · DOI 10.1002/cncr.33424
4. PSMA Theranostics: Current Landscape and Future Outlook.
   Zhang H, Koumna S, Pouliot F, Beauregard JM, et al · · 2021 · cited 45× · PMID 34439177 · DOI 10.3390/cancers13164023
5. Immune Checkpoint Inhibitors in Advanced Prostate Cancer: Current Data and Future Perspectives.
   Rebuzzi SE, Rescigno P, Catalano F, Mollica V, et al · · 2022 · cited 40× · PMID 35267553 · DOI 10.3390/cancers14051245
6. Lutetium-177-PSMA-I&T as metastases directed therapy in oligometastatic hormone sensitive prostate cancer, a randomized controlled trial.
   Privé BM, Janssen MJR, van Oort IM, Muselaers CHJ, et al · · 2020 · cited 33× · PMID 32928177 · DOI 10.1186/s12885-020-07386-z
7. Molecular Mechanisms of Prostate Cancer Development in the Precision Medicine Era: A Comprehensive Review.
   Maekawa S, Takata R, Obara W. · · 2024 · cited 27× · PMID 38339274 · DOI 10.3390/cancers16030523
8. A phase II randomized trial of RAdium-223 dichloride and SABR Versus SABR for oligomEtastatic prostate caNcerS (RAVENS).
   Hasan H, Deek MP, Phillips R, Hobbs RF, et al · · 2020 · cited 25× · PMID 32487038 · DOI 10.1186/s12885-020-07000-2