Active — Not RecruitingPhase 2

Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST).

United States115 participantsStarted 2021-12-16

Plain-language summary

The treatment regimen will consist of 4 doses of FPI-2265

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Participants aged ≥ 18 years.
✓. Participants must have the ability to understand and sign an approved informed consent (ICF).
✓. Participants must have the ability to understand and comply with all protocol requirements.
✓. Adenocarcinoma of prostate proven by histopathology.
✓. Life expectancy of 6 months or more.
✓. Unresectable metastases.
✓. Documented progressive disease (PD); progressive mCRPC will be based on at least 1 of the following criteria:
✓. Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal starting value is 1.0 ng/mL, if PSA is the only indication of progression.

✕. Less than 6 weeks from enrollment since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm, 177Lu-PSMA-617/other Lu-PSMA RLT or any other radionuclide therapy). Participants who received previous treatment with Ac-225 are excluded.
✕. Participants who received more than 4 prior lines of systemic therapy for CRPC.
✕. Urinary tract obstruction as evidenced by Tc-99m DTPA renal scan with diuretics.
✕. Participants with skeletal metastases presenting as a superscan on a 99m Tc MDP Bone Scan.
✕. Persistent baseline dry eye or dry mouth \> Grade 1 from prior RLT.
✕. Persistent prior AEs \> Grade 1 from prior anti-cancer therapies.
✕. Abnormal renal function (estimated glomerular filtration rate \< 60 mL/min), baseline Hgb \< 9g/dL, ANC \< 1.5 ×10\^9/L, platelets \< 100 ×10\^9/L, and prothrombin time, international normalized ratio or prothrombin time test ≥ 1.5 × ULN.
✕. Administration of an investigational agent ≤ 60 days or 5 half-lives, whichever is shorter, prior to Cycle 1, Week 0.

To evaluate the effect of FPI-2265 on prostate-specific antigen (PSA) in participants with mCRPC.

Timeframe: From start of treatment until 12 weeks after the first treatment.

NCT IDNCT05219500

SponsorFusion Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-30

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Participants aged ≥ 18 years.
✓. Participants must have the ability to understand and sign an approved informed consent (ICF).
✓. Participants must have the ability to understand and comply with all protocol requirements.
✓. Adenocarcinoma of prostate proven by histopathology.
✓. Life expectancy of 6 months or more.
✓. Unresectable metastases.
✓. Documented progressive disease (PD); progressive mCRPC will be based on at least 1 of the following criteria:
✓. Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal starting value is 1.0 ng/mL, if PSA is the only indication of progression.

✕. Less than 6 weeks from enrollment since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm, 177Lu-PSMA-617/other Lu-PSMA RLT or any other radionuclide therapy). Participants who received previous treatment with Ac-225 are excluded.
✕. Participants who received more than 4 prior lines of systemic therapy for CRPC.
✕. Urinary tract obstruction as evidenced by Tc-99m DTPA renal scan with diuretics.
✕. Participants with skeletal metastases presenting as a superscan on a 99m Tc MDP Bone Scan.
✕. Persistent baseline dry eye or dry mouth \> Grade 1 from prior RLT.
✕. Persistent prior AEs \> Grade 1 from prior anti-cancer therapies.
✕. Abnormal renal function (estimated glomerular filtration rate \< 60 mL/min), baseline Hgb \< 9g/dL, ANC \< 1.5 ×10\^9/L, platelets \< 100 ×10\^9/L, and prothrombin time, international normalized ratio or prothrombin time test ≥ 1.5 × ULN.
✕. Administration of an investigational agent ≤ 60 days or 5 half-lives, whichever is shorter, prior to Cycle 1, Week 0.