Node; ProstatePhase 2POSTCARDNCT03795207
Prostate Cancer With OligometaSTatic Relapse: Combining Stereotactic Ablative Radiotherapy and Durvalumab (MEDI4736)
A Phase 2 study testing SBRT + Durvalumab and SBRT in people with Node; Prostate and Bone Metastases, run by Institut Cancerologie de l'Ouest at 9 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Node; Prostate, Bone Metastases, Prostate Cancer Patients
- What is being tested?
- SBRT + Durvalumab and SBRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 9 sitesFrance
- Study dates
- 21 Mar 2019to 27 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
- Age > or = 18 years at time of study entry
- Histologically proven diagnosis of prostate cancer (PCa)
- PCa patients with a biochemical recurrence "Rising PSA" following treatment with curative intent (radical prostatectomy, primary radiotherapy or a combination of both) as defined by the EAU guidelines.
- A maximum of 5 bone or lymph node metastases, seen only on FCH-PET CT or Ga-PSMA PET CT, not seen on conventional imaging assessments (bone scan or thorax, abdomen and pelvis CT scan).
- WHO performance state 0-1
Show all 20Show fewer
- Controlled primary tumor. In case the PSA > 0,2 ng/ml in the postoperative setting patients are eligible if a multiparametic MRI or PET scan of the prostate bed rules out a local relapse.
- Patients after primary radiotherapy should undergo MRI of the prostate according to the European Society of Urogenital Radiology (ESUR) guidelines to rule out local relapse. In case of a suspicious lesion, a biopsy should confirm local recurrence and patients should be referred for local salvage prostatectomy when distant metastases are ruled out. If MRI rules out local relapse, patients are eligible.
- 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 8.5 nmol/l prior to inclusion.
- Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 103 /L (≥ 1500 per mm3)
- Platelet count ≥ 75 x 109/L (≥75,000 per mm3)
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysishaemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
- Measured creatinine clearance (CL) ≥ 40 ml/min or Calculated creatinine CL ≥ 40 ml/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Creatinine CL (ml/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Body weight > 30kg
- Life expectancy of > 24 months.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Social insurance
Who cannot join
- Serum testosterone level < 8.5 nmol/ml
- Vertebral metastases with a minimum distance inferior to 5 mm between GTV (gross tumor volume) and spinal cord
- Visceral metastases
- Bone metastases seen on bone scan
- Lymph nodes greater than 20 mm
- PSA doubling time less than 6 months
Show all 45Show fewer
- Spinal cord compression
- Any unresolved toxicity NCI CTCAE (v4.03) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen)
- Lung, Brain, Liver or other visceral metastases
- Relapsed primary tumor
- Perihilar lymphnode metastases
- Previous irradiation of the oligometastatic site using a dose > 20 Gy less than 5 years ago.
- Previous treatment with a cytotoxic agent for PCa
- Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids...)
- Particimmunotherapyation in another clinical study with an investigational product during the last 4 weeks
- 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
- Any prior immune therapy (CTLA-4, PD1 (Programmed cell death )1 or PD-L1 inhibitor, including durvalumab)
- 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)
- 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
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Durvalumab.
- History of allogenic organ transplantation.
- 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
- 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
- History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of immunotherapy and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B (known positive HBV (hepatitis B virus) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV (hepatitis B virus) infection (defined as the presence of hepatitis B core antibody [anti-HBc (hepatitis B core antigen)] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of immunotherapy. Note: Patients, if enrolled, should not receive live vaccine whilst receiving immunotherapy and up to 30 days after the last dose of immunotherapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Male patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Institut Bergonie
Bordeaux, 33076
CHRU de Brest
Brest, 29200
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Chbs Lorient
Lorient, 56100
Centre Léon Bérard
Lyon, 69373
Institut de Cancérologie de Montpellier
Montpellier, 34298
Hospices Civils de Lyon
Pierre-Bénite, 69310
ICO
Saint-Herblain, 44805
About this study
Official title: A Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Durvalumab (MEDI4736) in Oligometastatic Recurrent Hormone Sensitive Prostate Cancer Patients
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.
Read more
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.
- Conditions
- Node; Prostate, Bone Metastases, Prostate Cancer Patients
- Being tested
- SBRT + Durvalumab, SBRT
- Keywords
- Node; Prostate, Bone Metastases, Prostate cancer patients, SBRT (Stereotactic body radiation therapy), Durvalumab, TEP-FCH, TEP-PSMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT + DurvalumabCombination 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
SBRTRadiation
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 group | Role | What they receive |
|---|---|---|
| Arm SBRT + DURVALUMAB | Experimental | 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 Receives: Combination Product: SBRT + Durvalumab |
| Arm SBRT | Active comparator | Radiation (SBRT)
32 patients will be enrolled in this arm
Patients will receive only 3 fractions of radiation Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-years Progression-free survival
The primary outcome will be progression-free survival, defined as the time from randomization until a biochemical-clinical failure
Measured: 54 months
Secondary outcomes (8)
Health-related quality of life
Health-related quality of life will be evaluated using EORTC QLQ-PR25 instruments.Total score is reported
Measured: through study completion, an average of 7.5 year
Health-related quality of life
Health-related quality of life will be evaluated using self-administered EORTC QLQ-C30 questionnaire. Total score is reported
Measured: through study completion, an average of 7.5 year
Androgen deprivation therapy free survival
ADT will be started in both arms at time of polymetastatic disease, local progression of metastases or symptoms.
Measured: through study completion, an average of 7.5 year
Prostate cancer specific survival
Delay from randomization to death
Measured: through study completion, an average of 7.5 year
Overall survival
Delay from randomization to death
Measured: through study completion, an average of 7.5 year
Acute toxicity: Common toxicity criteria version 4.03
Common toxicity criteria version 4.03
Measured: through study completion, an average of 7.5 year
Late toxicity: Common toxicity criteria version 4.03
Common toxicity criteria version 4.03
Measured: through study completion, an average of 7.5 year
Time to resistance castration
serum testosterone measure
Measured: through study completion, an average of 7.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start21 Mar 2019
- Primary completion27 Dec 2023
- Study completion27 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Node; ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- STEPHANE SUPIOT, Study director, INSTITUT DE CANCEROLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795207
- Sponsor's protocol ID
- ICO-N-2017-08
- Acronym
- POSTCARD
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Durvalumab (MEDI4736) in Oligometastatic Recurrent Hormone Sensitive Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03795207
- Acronym / sponsor ID
- POSTCARD / ICO-N-2017-08
- Conditions
- Node; Prostate, Bone Metastases, Prostate Cancer Patients
- Keywords
- Node; Prostate, Bone Metastases, Prostate cancer patients, SBRT (Stereotactic body radiation therapy), Durvalumab, TEP-FCH, TEP-PSMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2027 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm SBRT + DURVALUMAB | Experimental | Combination Product: SBRT + DurvalumabRadiation (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 |
| Arm SBRT | Active comparator | Radiation: SBRTRadiation (SBRT) 32 patients will be enrolled in this arm Patients will receive only 3 fractions of radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
- Age > or = 18 years at time of study entry
- Histologically proven diagnosis of prostate cancer (PCa)
- PCa patients with a biochemical recurrence "Rising PSA" following treatment with curative intent (radical prostatectomy, primary radiotherapy or a combination of both) as defined by the EAU guidelines.
- A maximum of 5 bone or lymph node metastases, seen only on FCH-PET CT or Ga-PSMA PET CT, not seen on conventional imaging assessments (bone scan or thorax, abdomen and pelvis CT scan).
Key exclusion criteria (45 listed)
- Serum testosterone level < 8.5 nmol/ml
- Vertebral metastases with a minimum distance inferior to 5 mm between GTV (gross tumor volume) and spinal cord
- Visceral metastases
- Bone metastases seen on bone scan
- Lymph nodes greater than 20 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT + DurvalumabDurvalumab, 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 | Combination product | Arm SBRT + DURVALUMAB |
| SBRTSBRT (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 | Radiation | Arm SBRT |
Primary outcome
Two-years Progression-free survival
Time frame: 54 months
The primary outcome will be progression-free survival, defined as the time from randomization until a biochemical-clinical failure
8 secondary outcomes
Health-related quality of life
Time frame: through study completion, an average of 7.5 year
Health-related quality of life
Time frame: through study completion, an average of 7.5 year
Androgen deprivation therapy free survival
Time frame: through study completion, an average of 7.5 year
Prostate cancer specific survival
Time frame: through study completion, an average of 7.5 year
Overall survival
Time frame: through study completion, an average of 7.5 year
Acute toxicity: Common toxicity criteria version 4.03
Time frame: through study completion, an average of 7.5 year
Late toxicity: Common toxicity criteria version 4.03
Time frame: through study completion, an average of 7.5 year
Time to resistance castration
Time frame: through study completion, an average of 7.5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Node; Prostate
RecruitingPhase 2
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
Prostate Cancer
RecruitingObservational study
Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
Prostate Cancer
Active, not recruitingPhase 3
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
Recruiting
Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response
Prostate Adenocarcinoma, Iliac Nodal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
STEPHANE SUPIOT study director
INSTITUT DE CANCEROLOGIE DE L'OUEST
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT + Durvalumab and SBRT in people with Node; Prostate and Bone Metastases, run by Institut Cancerologie de l'Ouest at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-years Progression-free survival (time frame: 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.