NL-OMON54469招募中3 期
SPLASH: Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using 177Lu- PNT2002 PSMA Therapy After Second-line Hormonal Treatment - SPLASH
POINT BioPharma,0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male aged 18 years or older.
- •2. Histological, pathological, and/or cytological confirmation of
- •adenocarcinoma of the prostate.
- •3. Ineligible or averse to chemotherapeutic treatment options.
- •4. Patients must have progressive mCRPC at the time of consent based on at
- •least 1 of the following criteria:
- •a. Serum/plasma PSA progression defined as increase in PSA greater than 25% and
- •>2 ng/mL above nadir, confirmed by progression at 2 time points at least 3
- •weeks apart.
- •b. 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 a new lesion.
- •c. Progression of bone disease: defined as appearance of two or more new
- •lesions by bone scan.
- •5. Progression on previous treatment with one ARAT (abiraterone or enzalutamide
- •or darolutamide or apalutamide) in either the CSPC or CRPC setting.
- •6. PSMA-PET scan (i.e., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by
- •the sponsor's central reader.
- •7. Castrate circulating testosterone levels (<1.7 nmol/L or <50 ng/dL).
- •8. Adequate organ function, independent of transfusion:
- •a. Bone marrow reserve:
- •i. White blood cell (WBC) count >=2.5 × 109/L OR absolute neutrophil count (ANC)
- •>=1.5 × 109/L.
- •ii. Platelets >=100 × 109/L.
- •iii. Hemoglobin >=8 g/dL.
- •b. Liver function:
- •i. Total bilirubin <=1.5 × institutional upper limit of normal (ULN). For
- •patients with known Gilbert*s syndrome, <=3 × ULN is permitted.
- •ii. ALT or AST <=3.0× ULN.
- •c. Renal function:
- •i. Serum/plasma creatinine <=1.5 × ULN or creatinine clearance >=50 mL/min based
- •on Cockcroft-Gault formula.
- •d. Albumin >=30 g/L.
- •9. Human immunodeficiency virus-infected patients who are healthy and have a
- •low risk of acquired immunodeficiency syndrome-related outcomes are included in
- •this trial.
- •10. For patients who have partners who are pregnant or of childbearing
- •potential a condom is required along with a highly effective contraceptive
- •method during the study and for 6 months after last study drug administration.
- •Such methods deemed highly effective include
- •a) combined (estrogen and progestogen containing) hormonal contraception
- •associated with inhibition of ovulation
- •b) progestogen-only hormonal contraception associated with inhibition of
- •c) intrauterine device (IUD), d) intrauterine hormone-releasing system (IUS)
- •e) bilateral tubal occlusion
- •f) vasectomy
- •g) sexual abstinence.
- •11. Willing to initiate ARAT therapy (either enzalutamide or abiraterone),
- •pre-specified by investigator, if randomized to Treatment Arm B.
- 另有 5 项未显示
排除标准
- •1. If noted in pathology report, prostate cancer with known significant
- •(>10% present in cells) sarcomatoid or spindle cell or neuroendocrine
- •components. Any small cell component in the cancer should result in exclusion.
- •2. Prior treatment for prostate cancer <=28 days prior to randomization, with
- •the exclusion of first line local external beam, ARAT, luteinizing
- •hormone-releasing hormone (LHRH) agonist or antagonist therapy, or
- •non-radioactive bone-targeted agents.
- •3. Any prior cytotoxic chemotherapy for CRPC (e.g., cabazitaxel or docetaxel);
- •chemotherapy for hormone-sensitive prostate cancer (HSPC) is allowed if the
- •last dose was administered >1 year prior to consent.
- •4. Prior treatment with systemic radionuclides (e.g. radium-223, rhenium-186,
- •strontium-89).
- •5. Prior immuno-therapy, except for sipuleucel-T.
- •6. Prior PSMA-targeted radioligand therapy, e.g., Lu-177-PSMA-617, I 131-1095.
- •7. Prior poly ADP ribose polymerase (PARP) inhibitor for prostate cancer.
- •8. Patients who progressed on 2 or more lines of ARATs.
- •9. Patients receiving bone-targeted therapy (e.g. denosumab, zoledronic acid)
- •are excluded if they are not on stable doses for at least 4 weeks prior to
- •randomization.
- •10. Administration of an investigational agent <=60 days or 5 half-lives,
- •whichever is shorter, prior to randomization.
- •11. Major surgery <=30 days prior to randomization.
- •12. Estimated life expectancy <6 months as assessed by the principal
- •investigator.
- •13. Presence of liver metastases >1 cm on abdominal imaging.
- •14. A superscan on bone scan defined as a bone scan that demonstrates markedly
- •increased skeletal radioisotope uptake relative to soft tissues in association
- •with absent or faint genitourinary tract activity71.
- •15. Dose escalation or initiation of opioids for cancer-related pain <=30 days
- •prior to consent up to and including randomization.
- •16. Known presence of central nervous system metastases.
- •17. Contraindications to the use of planned ARAT therapy.
- •18. Active malignancy other than low-grade non-muscle-invasive bladder cancer
- •and non-melanoma skin cancer.
- •19. Concurrent illness that may jeopardize the patient*s ability to undergo
- •study procedures.
- •20. Serious psychological, familial, sociological, or geographical condition
- •that might hamper compliance with the study protocol and follow-up schedule.
- •Patients that travel need to be capable of repeated visits even if they are on
- •the control arm.
- •21. Symptomatic cord compression, or clinical or radiologic findings indicative
- •of impending cord compression.
- •22. Concurrent serious (as determined by the investigator) medical conditions,
- •including, but not limited to, New York Heart Association class III or IV
- •congestive heart failure, unstable ischemia, uncontrolled symptomatic
- •arrhythmia, history of congenital prolonged QT syndrome, uncontrolled
- •infection, known active hepatitis B or C, or other significant co-morbid
- •conditions that in the opinion of the investigator would impair study
- •participation or cooperation.
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