NBTXR3 Nanoparticles and EBRT or EBRT With Brachytherapy in the Treatment of Prostate Adenocarcinoma

Stopped early · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will receive only EBRT and the other group will receive a Brachytherapy boost and EBRT. Both groups will receive treatment with androgen deprivation. There will be 2 consecutive steps, a dose escalation and a subsequent dose expansion part.

Key facts

Study ID

NCT02805894

Run by

Nanobiotix

People needed

5

Starts

2017-11-15

Expected to finish

2020-03-19

Last updated by the study team

2021-05-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18
• Histologically confirmed adenocarcinoma of the prostate gland by needle core samples with assigned Gleason score
• Subjects ADT naive or subjects who are already on ADT treatment and scheduled to receive radiation therapy for their adenocarcinoma of prostate are eligible. An 8-week course of ADT is required to be completed prior to NBTXR3 administration and initiation of radiation therapy.
• Pelvic and para-aortic lymph nodes must be negative on CT-scan or MRI of the abdomen and pelvis performed within 12 weeks prior to enrollment into the study
• Prostate adenocarcinoma with High Risk (HR) and Unfavorable Intermediate Risk (UIR) for recurrence classification as determined by one of the following combinations:
• High risk (HR): subjects with one or more of the following risk factors:
• Clinical stage: T3/T4
• Gleason score (GS): 8-10
• PSA > 20
• N0
• Unfavorable Intermediate Risk (UIR): subjects with no HR features but with one or more of the following adverse risk factors:
• At least 2 of the following 3 factors: Gleason score(GS) 3+4=7 and/or PSA 10-20 and/or T2b/c
• Gleason score (GS) 4+3=7
• Greater than 50% of biopsy cores positive and at least one other risk factor:
• Gleason score (GS) 7 and/or PSA 10-20 and/or T2b/c
• No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if bone CT or MRI of hot spots are negative for metastasis
• Baseline serum PSA value performed with an FDA-approved assay within 120 days prior to registration. Study entry PSA should not be obtained within 10-day period following prostate biopsy or following initiation of hormonal therapy
• ECOG performance status must be 0 or 1
• Adequate function of bone marrow:
• Hemoglobin > 100 g/L
• Absolute Neutrophils > 1.5 x 109/L
• Platelets > 100 x 109/L,
• Adequate function of kidney:
• Serum creatinine < 1.5 x ULN
• Adequate function of liver:

You may not qualify if…

• Written Informed Consent not obtained, signed and dated
• History of colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases or proximal urethral stricture requiring dilatation
• Prostate size volume ≥90 cc
• Brachytherapy with EBRT in subjects whose prostate volume is >60cc
• Severe, active co-morbidity, defined as follows:
• Inflammatory bowel disease, active rectal diverticulitis, Crohn's disease affecting the rectum, anal stenosis or ulcerative colitis. (Nonactive diverticulitis and Crohn's disease not affecting the rectum are allowed)
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC (Centers for Disease Control) definition
• Prior invasive malignancy, except non-melanoma skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 2 years
• Subjects with congenital long QT syndrome or subjects taking Class IA, Class III or Class IC anti-arrhythmic medications will require a cardiologist's evaluation prior to eligibility assessment. subjects with cardiovascular diseases can be included as long as the benefits of androgen deprivation therapy outweigh the potential risk of cardiovascular events
• Uncontrolled lung disease
• Subjects with any evidence of distant metastases
• subjects with any contraindication to pelvic radiotherapy including, but not limited to, previous pelvic radiotherapy or brachytherapy
• Presence of bilateral hip replacement prostheses
• Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
• Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician
• Complete initial work up earlier than 12 weeks prior to subject registration
• Subjects unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Subjects participating in another clinical investigation at the time of signature of the informed consent.

Where it is running

• Dana Farber Cancer Institute/Brigham and Women's Hospital — Boston, Massachusetts, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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