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About
ACCEL is a multicenter, open label phase I/II study of [Ac-225]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
Full description
The primary aim of the phase I study is to evaluate the safety and tolerability of [Ac-225]-PSMA-62 to determine recommended phase II doses for patients with mCRPC and BCR prostate cancer. The aim of the phase II study for patients with mCRPC is to evaluate the efficacy of [Ac-225]-PSMA-62.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adults aged 18 years or older
Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate
Adequate organ function (bone marrow reserve, liver function, renal function)
Patients with human immunodeficiency virus who are healthy and have a low risk of acquired immunodeficiency syndrome-related outcomes are included in this trial.
Willing and able to comply with all study requirements and treatments (including [Ac-225]-PSMA-62) as well as the timing and nature of required assessments
ECOG performance status 0 to 2
Life expectancy of at least 6 months per investigator judgement
Patients and their female partner(s) of childbearing potential must agree to use two acceptable forms of contraception, one of which must be a barrier method during the study and for 21 weeks after last study drug administration.
The patient has read, understood, and signed the written informed consent form(s)
Criteria specific for patients with mCRPC:
Previously received treatment for their underlying disease and have exhausted all satisfactory or available approved treatment options
Progressive mCRPC at the time of consent based on at least 1 of the following criteria:
Positive PSMA-PET within 90 days of enrolment; note that either [Ga-68] or [F-18] PSMA targeted agents, approved for commercial use, may be used as per diagnostic standard of care
Castrate circulating testosterone levels (<1.74 nmol/L or <50 ng/dL)
Criteria specific for patients with BCR:
The patient's primary tumor must have been previously treated with surgery and/or definitive radiation. Prior salvage treatments (radiation or surgery) to the prostate bed or pelvis are allowed
Biochemical recurrence after primary therapy. Patients without any prior ADT, or those with prior ADT having recovered testosterone to within the normal range - defined as ≥5.2 nmol/L (≥150 ng/dL) - must meet the following thresholds for BCR:
Positive PSMA-PET within 90 days of enrolment. Either [Ga-68] or [F-18] PSMA targeted agents, which are approved by the respective health authority, may be used as per standard of care (diagnostic protocols) for each institution
No indication for urgent or emergent radiation
Patient has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan
Exclusion criteria
Patients with neuroendocrine or small cell carcinoma of the prostate
Major surgery ≤30 days prior to start of study treatment
Patient has received any other investigational therapeutic agents within 4 weeks or 5 halflives (whichever is shorter) of starting the study treatment
Evidence of ongoing and untreated urinary tract obstruction
History of grade 4 myelosuppression lasting > 7 days, or grade 3 myelosuppression requiring more than 6 weeks recovery
Patients receiving medications which are known to cause xerostomia or xerophthalmia (e.g. Darafenicin) are excluded if they are not on stable doses for at least 4 weeks prior to screening
Existing Grade 1 dry mouth (xerostomia) or symptomatic Grade 1 dry eye (xerophthalmia) for any reason
Contraindications to the use of planned [Ac-225]-PSMA-62 therapy, including but not limited to hypersensitivity to [Ac-225]-PSMA-62 excipients
Has a known history of other malignancy within the last 5 years. Except: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type
Patient has any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while on the study or that could confound discrimination between disease- and study treatment-related toxicities
Serious psychological, familial, sociological, or geographical condition that might hamper compliance with the study protocol and follow-up schedule.
Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
Inability to lie flat during or tolerate PET/CT or MRI
History of Torsades de Pointes or congenital prolonged QT syndrome
Concurrent serious (as determined by the investigator) medical conditions
Criteria specific for patients with mCRPC:
Criteria specific for patients with BCR:
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups
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Central trial contact
Richard Cioci
Data sourced from clinicaltrials.gov
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