Prostate cancer with OligometaSTatic relapse: Combining stereotactic Ablative Radiotherapy and Durvalumab (MEDI4736), a randomized phase II trial

Phase 1

• Conditions: oligometastatic hormone sensitive prostate cancer; MedDRA version: 20.0Level: LLTClassification code 10007463Term: Carcinoma prostaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2017-003827-31-FR
• Lead Sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-19
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 96

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

1.Serum testosterone level < 50 ng/ml
2.Vertebral metastases with a minimum distance inferior to 5 mm between GTV and spinal cord
3.Spinal cord compression
4.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 irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
5.PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen)
6.Lung, Brain, Liver or other visceral metastases
7.Relapsed primary tumor
8.Perihilar lymphnode metastases
9.Previous irradiation of the oligometastatic site using a dose > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified