[Ac-225]-PSMA-62 Phase I/II Clinical Trial to Characterize Efficacy, Safety, Tolerability, and Dosimetry in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (ACCEL)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

ACCEL is a multicenter, open label phase Ia/Ib/II study of \[Ac-225\]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate

• ECOG performance status 0 to 1

• Criteria specific for patients with mCRPC:

‣ Previously received an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy (unless ineligible or refused taxane). Received a maximum of 3 prior systemic therapy regimens in the mCRPC setting

⁃ Progressive mCRPC at the time of consent based on at least 1 of the following criteria being met in the context of castrate levels of testosterone:

• PSA progression defined as rising PSA values at a minimum of 1-week intervals, with the last result being at least 1.0 ng/mL

∙ Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions

∙ Progression of bone disease defined as the appearance of two or more new lesions by bone scan

⁃ At least one PSMA-PET positive lesion for prostate cancer

⁃ Castrate circulating testosterone levels (\<1.74 nmol/L or \<50 ng/dL)

• Criteria specific for patients with OmHSPC:

‣ PSA recurrence after radical prostatectomy (RP) or definitive radiation therapy (RT), with or without adjuvant/salvage local therapy (radiation or surgery), with or without (neo)adjuvant ADT

• PSA ≥ 0.2ng/mL for patients with prior RP +/- RT, or

∙ PSA of ≥ 2 ng/mL above nadir for patients with only prior RT

⁃ 1- 5 PSMA-PET positive lesions identified outside the prostate bed or remaining gland.

Locations
Other Locations
Canada
Juravinski
NOT_YET_RECRUITING
Hamilton
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
McGill University
RECRUITING
Montreal
Centre Hospitalier Universite de QUEBEC
RECRUITING
Québec
Hopital De Chicoutimi
NOT_YET_RECRUITING
Saguenay
Princess Margaret Cancer Centre
RECRUITING
Toronto
BC Cancer Vancouver
RECRUITING
Vancouver
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2032-12
Participants
Target number of participants: 142
Treatments
Experimental: OmHSPC
Patients with prostate cancer and biochemical recurrence after definitive surgery or radiation therapy, with 1-5 PSMA-positive lesions, who have not yet initiated lifelong hormone therapy.
Experimental: mCRPC
Patients with PSMA-positive mCRPC who have prior treatment with at least one APRI and received taxane chemotherapy (or ineligible/refused); and received a maximum of 3 prior systemic therapy regimens in the mCRPC setting.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov