CTRI/2022/03/041265Not yet recruitingPhase 2
177Lu-PSMA-617 radioligand therapy versus Docetaxel in High-volume Metastatic Hormone-sensitive Prostate Cancer: A Randomized, Controlled, Phase 2 Non-inferiority Trial (LADDER) - LADDER
All India Institute of Medical Sciences New Delhi0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Histologically proven adenocarcinoma prostate
- •High-volume metastatic disease (as established by 68Ga-PSMA-11 PET/CT) defined as presence of visceral metastasis or >=4 bone lesions with at least one extra-axial lesion
- •Significant PSMA expression in 68Ga-PSMA-11 PET/CT defined as avidity of lesion being greater than that of normal liver
- •ECOG performance 0-2
- •Adequate renal function â?? eGFR >= 30 mL/min
- •Stable haematological parameters:
- •oHb >= 8 g/dL
- •oNeutrophils >= 1500/mcL
- •oPlatelets >= 75000/mcL
- •Adequate liver function:
- •oBilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)
- •oAST or ALT <= 1.5 x ULN (or <= 5.0 x ULN in the presence of liver metastases)
- •oAlbumin >= 2.5 g/dL
- •Prior treatments allowed:
- •oFor de-novo mHSPC: prior ADT allowed if commenced within 90 days of randomization and no evidence of progressive disease; prior palliative radiotherapy or surgery allowed if conducted >=4 weeks prior to randomization
- •oFor localized PCa progressing to mHSPC (all treatments completed >=6 months prior to randomization)
- •ï?§<=36 months of ADT
- •ï?§All other forms of prior therapies including radiation therapy, prostatectomy and lymph node dissection
Exclusion Criteria
- •Prostate cancer with sarcomatous/spindle cell/small cell differentiation
- •PSMA expression in 68Ga-PSMA-11 PET/CT less than liver
- •Sjogren Syndrome
- •Active malignancy other than prostate cancer
- •Concurrent illness, including severe infection
- •Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception
- •Prior treatment with docetaxel or novel anti-androgens
Investigators
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