Laparoscopic radical nephrectomy for clinical stage T2 renal tumors is effective with the advantages of less blood loss, shorter hospital stay, decreased analgesic requirement and rapid recovery compared with open radical nephrectomy. Long-term results are also similar in the 2 groups of patients. Laparoscopic radical nephrectomy for large tumors is a technically difficult, challenging procedure and it should be attempted by surgeons with significant experience.
antigen (PSA) level estimation, the International Prostate Symptom Score (IPSS), peak urinary flow rate (Q max ), and transabdominal ultrasonography to estimate prostate size and postvoid urine residue (PVR). The operative duration, blood loss, resected tissue weight, change in levels of haemoglobin and serum sodium, nursing contact time, duration of catheterization, and complications were noted. After surgery patients were reassessed for the IPSS, Q max and PVR at 6 months and 1 year.
RESULTSThe patients in all three groups had comparable characteristics before surgery. The mean operating duration and intraoperative irrigant used for TUVRP was less than for HOLEP or TURP, and blood loss with HOLEP and TUVRP was less than with TURP (all P < 0.001). Postoperative irrigation, nursing contact time, and catheter duration were significantly less for HOLEP than TURP or TUVRP, and for TUVRP than TURP. At followup, patients in all groups had a significant improvement from baseline in IPSS, Q max, and PVR, but the differences between the groups were not significant at 6 months or 1 year.
CONCLUSIONSHOLEP and TUVRP are both acceptable alternatives to TURP for treating large prostate glands, with less perioperative morbidity and comparable efficacy at 6 months and 1 year.
Rationale:
Despite the success of several standards of care treatment options in metastatic castration-resistant prostate cancer (mCRPC), a significant number of patients attain therapeutic resistance and eventually develop disease progression. Managing these patients are currently challenging. Hence, there is an unmet need for further efficient therapeutic options that induce anti-tumor activity and improve survival. The objective of this study was to assess the safety and therapeutic efficacy of
225
Ac-PSMA-617 targeted alpha therapy (TAT) in mCRPC patients in real-world conditions.
Methods:
In this prospective study, we recruited patients with mCRPC who either were refractory to
177
Lu-PSMA-617 radioligand therapy (RLT) or did not receive previous
177
Lu-PSMA-617 RLT. Patients were treated with
225
Ac-PSMA-617 TAT (100 KBq/Kg body weight) at 8-weekly intervals. The primary endpoint included the assessment of biochemical response by measuring the serum prostate-specific antigen (PSA) response rate as per the prostate cancer working group criteria (PCWG3). Secondary endpoints comprised the estimation of overall survival (OS), progression-free survival (PFS), molecular tumor response assessment (PERCIST 1 criteria), disease control rate (DCR), toxicity according to CTCAE v5.0, and clinical response evaluation.
Results:
A total of 28 patients were recruited for this cohort study among whom 15 (54%) received prior
177
Lu-PSMA-617 RLT and the remaining 13 (46%) patients were
177
Lu-PSMA-617 RLT naïve. The mean age was 69.7 years (range: 46-87 years). All patients, except one, had extensive skeletal metastases on baseline
68
Ga-PSMA-11 PET/CT scan; one patient had lymph node dominant disease and advanced primary prostatic tumor. The mean activity administered was 26.5 ± 12 MBq (range: 9.25 - 62.9 MBq) [715.5 ± 327 µCi, range: 250 - 1700 µCi] with a median of 3 cycles (range: 1 - 7 cycles). At 8
th
week of post first cycle of
225
Ac-PSMA-617 therapy (initial follow-up) and the end of the follow-up, >50% decline in PSA was observed in 25% and 39%, respectively. The median PFS and OS were 12 months (95% CI: 9 - 13 months) and 17 months (95% CI: 16 months - upper limit not reached), respectively. Molecular tumor response by PERCIST 1 criteria could be conducted in 22/28 (78.6%) patients, which revealed complete response in 2/22 (9%), partial response in 10/22 (45.4%) patients, 2/22 (9%) with stable disease, and 8/22 (36%) with progressive diseases. The disease control rate, according to the biochemical and molecular tumor response criteria, was 82% and 63.6%, respectively. Multivariate analysis revealed PSA progression as adverse prognostic indicator of OS, and any PSA decline as a good prognostic indicator of PFS. There was no Grade III/IV toxicity no...
Renal cell carcinoma (RCC) represents one of the most resistant tumors to radiation and chemotherapy. Current therapies for RCC patients are inefficient due to the lack of diagnostic and therapeutic markers. Our recent studies have suggested an association of sperm-associated antigen 9 (SPAG9) with ovarian carcinomas. In the present study, we investigated the clinical relevance of SPAG9 in RCC patients. RT-PCR analysis showed expression of SPAG9 transcript in RCC tissues and RCC cell lines. In situ RNA hybridization and immunohistochemistry analyses confirmed the expression of SPAG9 in 88% of cancer patients, suggesting that SPAG9 participates in renal cancer. In addition, immunoblotting and ELISA analyses revealed a humoral immune response against SPAG9 in the sera of RCC patients but not in healthy individuals. Consistent with the clinical findings, knockdown of SPAG9 expression in RCC cells with specific siRNA significantly reduced cell growth and colony formation. Using in vitro wound healing and Matrigel invasion assays, we found that cell migration and invasive ability were also significantly inhibited. Furthermore, in vivo xenograft studies in nude mice revealed that administration of a SPAG9 siRNA plasmid significantly inhibited tumor growth. In conclusion, SPAG9 expression is associated with clinicopathologic features of tumors, suggesting that SPAG9 could contribute to the early spread of cancer. These results indicate that SPAG9 may have a role in tumor development and metastasis and thus could serve as a novel target for early detection and treatment of RCC. [Cancer Res 2008;68(20):8240-8]
Purpose
The aim of this study was to evaluate the efficacy and safety of 177Lu-PSMA-617 radioligand therapy in metastatic castration-resistant prostate cancer (mCRPC).
Methods
In this prospective, single-arm, single-institutional study, 90 mCRPC patients with progressive disease (PD) on second-line hormonal therapy and/or docetaxel chemotherapy were recruited for the study. All patients underwent diagnostic 68Ga-PSMA-HBED-CC PET/CT, prior to inclusion for therapy. Included patients underwent 177Lu-PSMA-617 therapy at 8- to 12-weekly intervals. The primary end point was to assess the overall survival. The secondary and cosecondary end points included biochemical response assessment as per the Prostate Cancer Working Group 3 criteria, progression-free survival, radiological and molecular response criteria, clinical response, safety profile, and disease control rates. All the outcome parameters were evaluated in 90 patients except for the radiographic and molecular response, which was evaluated in 69 patients.
Results
The median age of patients was 66.5 years (range, 30–88 years). The median activity administered per cycle was 3.7 to 8 GBq ranging from 1 to 7 cycles, and patients were followed up over a median duration of 28 months. At 2- to 3-month interval after the first therapy and the end of the assessment, greater than 50% decline in prostate-specific antigen was observed in 32.2% and 45.5%, respectively. Univariate analysis did not reveal any variables such as prior therapies, laboratory parameters, concomitant hormonal therapy, and SUV patient parameters associated with prostate-specific antigen decline. Radiographic response by diagnostic CT revealed partial remission in 23% (16/69), stable disease in 54% (37/69), and PD in 23% (16/69) of patients. Molecular tumor response by PET Response Criteria in Solid Tumor 1 criteria revealed 19 (27.5%) of 69 patients with partial remission, 30 (43.5%) of 69 with stable disease, and 20 (29%) of 69 with PD. The disease control rates according to the radiographic and molecular response were 77% and 71%, respectively. The median overall survival and median progression-free survivals were 14 and 11.8 months, respectively. Toxicities related to radioligand therapy were low and transient with no serious adverse effects.
Conclusions
177Lu-PSMA-617 radionuclide therapy is a safe and effective approach to the treatment of mCRPC patients.
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