scholarly journals Combined abiraterone acetate plus prednisone, salvage prostate bed radiotherapy and LH-RH agonists (CARLHA-GEP12) in biochemically-relapsing prostate cancer patients following prostatectomy: A phase I study of the GETUG/GEP

Oncotarget ◽  
2018 ◽  
Vol 9 (31) ◽  
pp. 22147-22157
Author(s):  
Stéphane Supiot ◽  
Loic Campion ◽  
Pascal Pommier ◽  
Mélanie Dore ◽  
Clément Palpacuer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Study ◽  
Abiraterone Acetate ◽  
Prostate Bed ◽  
Lh Rh

The anti-interleukin-6 antibody siltuximab down-regulates genes implicated in tumorigenesis in prostate cancer patients from a phase I study

The Prostate ◽  
2011 ◽  
Vol 71 (13) ◽  
pp. 1455-1465 ◽  
Author(s):  
Jayaprakash Karkera ◽  
Hannes Steiner ◽  
Weimin Li ◽  
Viktor Skradski ◽  
Patrizia L. Moser ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Interleukin 6 ◽  
Phase I Study

Combined abiraterone, salvage prostate bed radiotherapy and LH-RH agonists (CARLHA) in biochemically-relapsing prostate cancer patients following prostatectomy: A phase I study of the GETUG/GEP.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 45-45 ◽  
Author(s):  
Stephane Supiot ◽  
Loic Campion ◽  
Pascal Pommier ◽  
Melanie Dore ◽  
Severine Racadot ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Dose Level ◽  
Liver Toxicity ◽  
Maximum Tolerated Dose ◽  
Abiraterone Acetate ◽  
Recommended Dose ◽  
Level 1 ◽  
Grade 3 ◽  
Lh Rh

45 Background: Salvage radiotherapy (RT) plus 6 months LH-RH therapy (ADT) improves biochemical relapse free survival in men with rising PSA following prostatectomy. Abiraterone acetate (Aa) increases overall survival in metastatic prostate cancer. We aimed to establish the toxicity of adding Aa combined with salvage RT and 6 months goserilin (Gos). Methods: We enrolled pT2-pT4a pN0 prostate cancer patients (pts) with rising PSA (0.2 to <2.0 μg/l) following radical prostatectomy. The primary endpoint was to determine the Maximum Tolerated Dose and recommended dose of Aa during RT plus Gos, two dose levels tested : 1 (750mg) and 2 (1000 mg). Two different schemes were explored: Sheme A: Aa (1000 mg) and predisone (10 mg) were given orally during 1 month to salvage IMRT (66 Gy in 33 fractions). The first day of irradiation, Aa is reduced to level 1 or 2 and 10.8 mg Gos is injected (sc). In sheme B, Gos is injected the first day (1 month before starting RT). Results: We recruited 9 + 9 pts in scheme A and B respectively. In scheme A, Testosterone (Tst) levels declined to castration level (<0.5ng/ml) after 10 days . Two/9 pts did not achieve castration levels at 30 days. Median LH levels increased to 10.4 (D10) and 12.5 IU/l (D20). At dose level 1, 4/9 pts (44%) experienced grade 3 hepatitis, occurring prior to RT or during RT (8 Gy, 36 and 54 Gy). We hypothesized that this unexpected liver toxicity was related to the LH increase during the first month (Aa administration without Gos). Therefore, we modified LH-RH administration (scheme B) and recruited 9 more pts. Tst levels dropped to undetectable at day 6, while median LH levels decreased to 6.1 (D10) and 1.7 IU/l (D20). At dose level 1 (3 + 3 pts), no grade 3 liver toxicity was reported. No other grade 3 toxicity was recorded. At dose level 2, 2/3 pts had grade 3 hepatitis occurring during RT. CYP17 polymorphism did not correlate with liver toxicity. Conclusions: The recommended dose of Aa combined to short-term androgen deprivation and salvage RT is 750 mg. Aa alone did lead to castration levels in 22% of pts.An unexpected high frequency of grade 3 liver toxicity was observed. Clinical trial information: NCT01780220.

BAY 1075553 PET-CT for Staging and Restaging Prostate Cancer Patients: Comparison with [18F] Fluorocholine PET-CT (Phase I Study)

2014 ◽  
Vol 17 (3) ◽  
pp. 424-433 ◽  
Author(s):  
Mohsen Beheshti ◽  
Thomas Kunit ◽  
Silke Haim ◽  
Rasoul Zakavi ◽  
Christian Schiller ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Study ◽  
Pet Ct

scholarly journals Phase I study of BIBF 1120 with docetaxel and prednisone in metastatic chemo-naive hormone-refractory prostate cancer patients

2011 ◽  
Vol 105 (11) ◽  
pp. 1640-1645 ◽  
Author(s):  
G Bousquet ◽  
J Alexandre ◽  
C Le Tourneau ◽  
F Goldwasser ◽  
S Faivre ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Study ◽  
Hormone Refractory Prostate Cancer ◽  
Hormone Refractory ◽  
Bibf 1120

Effect of immunization with the ii-key modified HER2/neu(776-790) (AE37) peptide vaccine on pre-existent immunity to PSA in HLA-A24+ prostate cancer patients: Association with increased AE37-specific immunologic responses.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15125-e15125
Author(s):  
Sonia A. Perez ◽  
Eleftheria Anastasopoulou ◽  
Efi Pappou ◽  
Nikolaos Fragkiskos Pistamaltzian ◽  
Eric von Hofe ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
T Cells ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Study ◽  
Peptide Vaccine ◽  
Therapeutic Vaccine ◽  
Immunological Responses ◽  
Her 2 ◽  
Mhc Alleles

e15125 Background: In solid tumors such as prostate cancer, novel biomarkers are needed for assessing immunological responses and clinical efficacy. By using dextramers specific for PSA we have retrospectively analyzed CD8+ T cell frequencies in patients with HER-2/neu+ prostate cancer who had received the AE37 vaccine in a phase I study (Perez SA et al Clin. Cancer Res. 2010, 16:3495). AE37 binds to numerous MHC alleles (Perez SA et al Clin. Cancer Res. 2010, 16:3495) (Salazar LG, Clin Cancer Res. 2003, 9:5559) encouraging its use as a therapeutic vaccine for general HER-2/neu+ cancer patients. Methods: CD8+ Dextramer+ T cells were measured, retrospectively, in the blood (which was stored in N2 liquid) of HLA-A24+ (n= 12) and HLA-A2+ (n=12) patients. Blood lymphocytes collected before, during and 6-months post vaccination were all analyzed with the same method involving direct labeling with HLA A24/PSA(153-161)-FITC and PerCP-conjugated anti-CD8 monoclonal antibody. Results: 8 of 12 HLA-A24+ patients had preexistent immunity to PSA as evidenced by the increased percentages of CD8+ HLA-A24/PSA(153-161)+ T cells in pre-vaccination samples. All of these patients had shown increased in vitro (IFNγ-based ELISPOT assay) and in vivo (DTH) immunological responses to the AE37 vaccine in the phase I study (Perez SA et al Clin. Cancer Res. 2010, 16:3495). Importantly, this preexistent immunity was significantly boosted in 5 patients during vaccinations with AE37, was slightly increased in 2 others, whereas in one patient no changes were observed during vaccinations. Conclusions: These results suggest that HLA-A24 expression along with preexistent immunity to PSA(153-164) may represent biomarkers based on which HER-2/neu+ patients can be selected most likely to benefit from vaccination with AE37. A phase II trial is warranted for validating these results. Given the promiscuity of AE37, it would be intriguing to examine if preexistent immunity to other prostate antigens restricted by various MHC alleles exist and to demonstrate an increase in preexistent immunity in association with a positive immunologic response to vaccination with AE37.

Cross-trial Analysis of Immunologic and Clinical Data Resulting From Phase I and II Trials of MVA-5T4 (TroVax) in Colorectal, Renal, and Prostate Cancer Patients

2010 ◽  
Vol 33 (9) ◽  
pp. 999-1005 ◽  
Author(s):  
Richard Harrop ◽  
William Shingler ◽  
Michelle Kelleher ◽  
Jackie de Belin ◽  
Peter Treasure
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Clinical Data ◽  
Trial Analysis ◽  
Phase I And Ii
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