Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)
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|ClinicalTrials.gov Identifier: NCT04647526|
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : April 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-Resistant Prostate Cancer||Drug: [Lu-177]-PNT2002 Drug: Abiraterone Drug: Enzalutamide||Phase 3|
The primary objective of the study is to determine the efficacy of [Lu-177]-PNT2002 ([Lu-177]-PSMA-I&T) versus abiraterone or enzalutamide in delaying radiographic progression in patients with mCRPC.
The study consists of 3 phases: Dosimetry, Randomized Treatment, and Long term Follow up.
The study will commence with a 25-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment phase in approximately 390 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either [Lu-177]-PNT2002 (Arm A), or enzalutamide or abiraterone (Arm B). Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility, may crossover to receive [Lu-177]-PNT2002. All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3).
Only patients that meet PSMA PET avidity criteria per central review will be eligible for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||415 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)|
|Actual Study Start Date :||February 25, 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2028|
Experimental: [Lu-177]-PNT2002 (Arm A)
[Lu-177]-PNT2002 (6.8 GBq (±10%) every 8 weeks for 4 cycles)
Participants randomized to Arm A will receive 6.8 GBq (±10%) of [Lu-177]-PNT2002 every 8 weeks for 4 cycles
Other Name: [Lu-177]-PSMA-I&T
Active Comparator: Control Arm (Arm B)
Abiraterone (1000 mg orally qd with: 5 mg bid prednisone or 0.5 mg qd dexamethasone) or enzalutamide (160 mg orally qd).
Abiraterone (1000 mg orally qd with: 5 mg bid prednisone or 0.5 mg qd dexamethasone)
Enzalutamide (160 mg orally qd)
- Radiographic Progression Free Survival (rPFS) [ Time Frame: 32 weeks ]Time in months from the date of randomization to radiological progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) or confirmed progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3) (bone), or death from any cause, as assessed by blinded independent central review (BICR).
- Objective Response Rate (ORR) [ Time Frame: 32 weeks ]Proportion of patients with partial or complete response (PR or CR, respectively) by BICR based on RECIST 1.1 criteria (soft tissue) and PCWG3 criteria (bone).
- Duration of response [ Time Frame: 32 weeks ]Time from the first date of CR or PR by BICR to the first occurrence of radiographic progression (PD) by BICR based on PCWG3 modified RECIST 1.1.
- Overall Survival [ Time Frame: 5 years ]Time from the date of randomization until death due to any cause.
- PSA Response [ Time Frame: 32 weeks ]Proportion of patients achieving a ≥50% decrease in PSA (PCWG3 criteria) from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.
- Biochemical Progression-Free Survival (bPFS) [ Time Frame: 32 weeks ]Time from randomization to the date of the first PSA increase from baseline ≥25% and ≥2 ng/mL above nadir confirmed by a second PSA measurement defining progression ≥3 weeks later, as per PCWG3.
- Safety and Tolerability (AEs) [ Time Frame: 5 years ]Frequency and severity of AEs, graded and categorized using CTCAE v. 5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647526
|Contact: Jessica Jensen||+1-833-544-2637 ext 102||SPLASH@pointbiopharma.com|
|United States, Maryland|
|Chesapeake Urology Associates (CUA) P.A.||Recruiting|
|Towson, Maryland, United States, 21204|
|United States, Nebraska|
|Urology Cancer Center, PC||Recruiting|
|Omaha, Nebraska, United States, 68130|
|United States, Texas|
|Excel Diagnostics & Nuclear Oncology Center||Recruiting|
|Houston, Texas, United States, 77402|
|Jewish General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3T 1E2|
|Study Director:||Jessica Jensen||POINT Biopharma|