An Early Phase 1 interventional study of 2.0 GBq of 177Lu-EB-PSMA in Prostate Cancer, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Treatment
In recent years, quite a few studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in metastatic castration resistant prostate cancer (mCRPC), which has been shown desired effect. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, we conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu. This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.
Prostate cancer is one of the most common cancers and the second most frequent cause of cancer deaths for adult men. With the advances in the diagnosis and treatment of prostate cancer, some patients with localized prostate cancer can achieve good curative results, but there are still 10%～20% of patients progress to metastatic castration-resistant prostate cancer (mCRPC) every year, only one third of patients with mCRPC survive more than five years. Radioligand therapy targeting prostate specific membrane antigen (PSMA), which is overexpressed in most prostate cancer and even further increased in metastatic and castration-resistant carcinomas, has been demonstrated as an effective and safe therapy in men with mCRPC. 177Lu-PSMA-617 has also shown desired effect. However, 177Lu-PSMA-617, as a small molecule imaging agent, is cleared very quickly from the circulation. Therefore, radiotherapy that is based on small molecules requires high doses and frequent administrations, leading to systemic toxicity. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu. The investigators have published some articles demonstrated 177Lu-EB-PSMA had much higher accumulation in prostate cancer lesions than 177Lu-PSMA-617 and also showed an ideal effect. This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 30 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The patients were intravenously injected with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
Drug: 2.0 GBq of 177Lu-EB-PSMA
Patients were intravenous administrated with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA every 8 weeks (±1 week) for a maximum of 3 cycles.
Therapeutic effect: PSA Response
The serum PSA response was documented monthly until 8 weeks after the last treatment therapy, which can effectively reflect the treatment effect of prostate cancer. Biochemical response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase \<25% or PSA decrease \<50%.
Time frame: through study completion, an average of 1 month
Therapeutic effect: 68Ga-PSMA PET/CT Response
68Ga-PSMA-617 wholebody PET/CT acquisitions 8 weeks after each cycle of treatment. The molecular response was classified according to adapted modified PERSIST 1.0 criteria. Complete response (CR) was complete resolution of 68Ga-PSMA-617 uptake in the target lesions. Partial response (PR) was defined as ≥30% decrease in the SUVmax of the target lesions and total Lesions PSMA from the baseline scan, and ≥ 30% increase in the SUVmax value of the target lesions and total Lesions PSMA from the baseline scan was taken as progressive disease (PD). Neither CR, PR nor PD was considered stable disease (SD) that was \<30% decrease or \<30% increase of the target lesion. Changes of SUV (ΔSUV) between pre- and post-therapeutic PET were calculated.
Time frame: through study completion, an average of 2 months
Adverse events collection: Blood tests
Blood tests including hematologic status, liver function, and renal function were performed before and every two weeks after each cycle of treatment for a period of 8 weeks. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Time frame: through study completion, an average of 1 month
Started Jan 2019 (actual). Primary completion is estimated for Sep 2022, 43 months after the start.
Of 210 non-industry phase 1 interventional studies under Prostatic Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 78. This study's planned 43 months is close to that.
Counting every sponsor, half of 390 studies reached it within 43 months; a quarter within 23 and three quarters within 68.
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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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