Prostate carcinoma- clinical trial

Prostate carcinoma- clinical trial

1. NAMED TRIALS IN
PROSTATE CANCER
Dept of Urology
Govt Royapettah Hospital and Kilpauk Medical College
Chennai

1

2. MODERATORS:
Professors:
Prof. Dr. G. Sivasankar, M.S., M.Ch.,
Prof. Dr. A. Senthilvel, M.S., M.Ch.,

Asst Professors:
Dr. J. Sivabalan, M.S., M.Ch.,
Dr. R. Bhargavi, M.S., M.Ch.,
Dr. S. Raju, M.S., M.Ch.,
Dr. K. Muthurathinam, M.S., M.Ch.,
Dr. D. Tamilselvan, M.S., M.Ch.,
Dr. K. Senthilkumar, M.S., M.Ch.
DEPT OF UROLOGY, GRH AND KMC, CHENNAI. 2

3. NAMED TRIALS IN PROSTATE CANCER
PIVOT Trial
ProtecT Trial
STAMPEDE Trial
CHAARTED TRIAL
LATITUDE Trial
REDUCE Trial
PROMIS Trial
PREVAIL Trial

TROPIC Trial
FIRSTANA Trial
AFFIRM Trial
ALSYMPCA Trial
GETUG AFU 15 Trial
TAX327 Trial
IMPACT Trial
TERRAIN Trial


COU AA 301 Trial
SPCG 4 Trial
ORIOLE Trial
STOMP Trial
CAPSURE Study
TITAN Trial
RADICALS Trial
RAVES Trial





STRIVE Trial
SPARTAN Trial
SWOG 8794 Trial
ARO 96-02 Trial

3 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

4. STUDIES REGARDING PSA SCREENING
PLCO Trial – Prostate, Lung, Colorectal and Ovarian cancer screening trial
ERSPC – European Randomised Study of Screening for Prostate Cancer
PCPT – Prostate Cancer Prevention Trial
USPSTF – United States Preventive Services Task Force
4 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

5. AIM
To determine which of two strategies is superior for
the management of clinically localized CAP:
1)Radical prostatectomy with early aggressive
intervention for disease persistence or
recurrence,
2)Expectant management with reservation of
therapy for palliative treatment of symptomatic
or metastatic disease progression.
DURATION
1994-2010.
PIVOT Trial
Prostate Cancer
Intervention Versus
Observation Trial
5 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

6. DEATH FROM
ANY CAUSE
6 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

7. DEATH FROM
PROSTATE
CANCER
7 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

8. CONCLUSION
Among men with localized prostate cancer detected during the early era of PSA
testing:
Radical prostatectomy did not significantly reduce all-cause or prostate-cancer
mortality, as compared with observation, through at least 12 years of follow-up.
8 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

9. OBJECTIVE
To compare active monitoring, radical prostatectomy,
and external-beam radiotherapy for the treatment
of clinically localized prostate cancer.
DURATION
1999 - 2009

ProtecT Trial
Prostate Testing for
Cancer and
Treatment

9 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

10. ProtecT Trial
10 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

11. CANCER
SPECIFIC
SURVIVAL
ProtecT Trial
11 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

12. FREEDOM FROM
DISEASE
PROGRESSION
ProtecT Trial
12 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

13. CONCLUSION
At a median of 10 years, prostate-cancer–specific mortality was low irrespective of
the treatment assigned, with no significant difference among treatments.
Surgery and radiotherapy were associated with lower incidences of disease
progression and metastases than was active monitoring.
13 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

14. AIM
To compare docetaxel (given either every three
weeks or weekly) plus daily prednisone with
mitoxantrone plus prednisone.
DURATION
2000-2002.
TAX327 Trial
Docetaxel plus
Prednisone or
Mitoxantrone plus
Prednisone for
Advanced Prostate
Cancer
14 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

15. OVERALL
SURVIVAL
15 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

16. CONCLUSION
When given with prednisone, treatment with docetaxel every three weeks led to
superior survival and improved rates of response in terms of pain, serum PSA level,
and quality of life, as compared with mitoxantrone plus prednisone.
16 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

17. AIM
Evaluate multiple therapeutic strategies in the
management of high-risk locally advanced and
metastatic hormone-naïve prostate cancer.
Each novel treatment strategy is compared against a
single, contemporaneous control arm.
DURATION
Open since 2005.
STAMPEDE
Trial
Systemic Therapy
in Advancing or
Metastatic Prostate
Cancer: Evaluation
of Drug Efficacy

17 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

18. STAMPEDE TRIAL
2008

5 ORIGINAL
COMPARISONS
18 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

19. 19 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

20. ARM B - ZOLEDRONIC ACID
Prostate cancer cells can spread to bones and weaken them. Zoledronic acid is a
drug that reduces bone destruction and hardens bones.
The results of STAMPEDE show that the addition of zoledronic acid alone does not
prolong life expectancy.

20 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

21. ARM C - DOCETAXEL
Addition of docetaxel to hormone treatment does improve life expectancy, most
markedly in people with metastatic disease.
Delays time to progression or relapse for people with locally-advanced and
metastatic disease.
Docetaxel may now be given as part of standard treatment to all suitable people
entering STAMPEDE (from protocol v14.0).

21 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

22. ARM D - CELECOXIB
Recruitment stopped early as an earlier analysis failed to demonstrate sufficient
benefit.
Celecoxib does not improve life expectancy.

22 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

23. ARM E – DOCETAXEL + ZOLEDRONIC ACID
Zoledronic acid did not provide additional benefit when combined with docetaxel.
ARM E – CELECOXIB + ZOLEDRONIC ACID
No benefit overall.
23 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

24. STAMPEDE
Trial -
Current
24 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

25. OBJECTIVE
To study how well the estrogen skin patch works
compared with luteinizing hormone-releasing
hormone agonist injections in treating patients with
locally advanced or metastatic prostate cancer.
DURATION
Study started in 2006.
Estimated completion in 2021.

PATCH Trial
Prostate
Adenocarcinoma
TransCutaneous
Hormones
25 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

26. AIM
To assess whether concomitant treatment with ADT
plus docetaxel would result in longer overall survival
than that with ADT alone.
DURATION
Study designed by ECOG in 2005.
CHAARTED
Trial
ChemoHormonal
Therapy Versus
Androgen Ablation
Randomized Trial for
Extensive Disease in
Prostate Cancer
26 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

27. CHAARTED Trial-
STUDY PLAN
27 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

28. CHAARTED
TRIAL
28 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

29. CONCLUSION
Six cycles of docetaxel at the beginning of ADT for metastatic prostate cancer
resulted in significantly longer overall survival than that with ADT alone.
29 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

30. AIM
To investigate the effects of the addition of
docetaxel to androgen-deprivation therapy (ADT)
for patients with metastatic non-castrate prostate
cancer.
DURATION
2004-2008.
GETUG AFU
15 Trial
Hormone Therapy
and Docetaxel or
Hormone Therapy
Alone in Treating
Patients With
Metastatic Prostate
Cancer
Groupe d’Etude des Tumeurs Uro-Genital and Association
Francaise d’Urologie
30 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

31. OVERALL
SURVIVAL
31 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

32. PROGRESSION
FREE SURVIVAL
32 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

33. COMPLICATIONS
33 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

34. CONCLUSION
Docetaxel should not be used as part of first-line treatment for patients with non-
castrate metastatic prostate cancer.
34 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

35. OBJECTIVE
To determine if newly diagnosed (within previous 3
months) participants with metastatic hormone-naive
prostate cancer (mHNPC),
who have high-risk prognostic factors will benefit
from,
the addition of abiraterone acetate and low-dose
prednisone to androgen deprivation therapy.
DURATION
Study started in 2013.

LATITUDE
Trial
A Study of Abiraterone
Acetate Plus Low-Dose
Prednisone Plus
Androgen Deprivation
Therapy (ADT) Versus
ADT Alone in Newly
Diagnosed Participants
With High-Risk,
Metastatic Hormone-
Naive Prostate Cancer

35 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

36. INTERIM ANALYSIS 2017 - CONCLUSION
The addition of abiraterone
acetate and prednisone to ADT
significantly increased:
overall survival and
radiographic progression-free
survival
in men with newly diagnosed,
metastatic, castration-sensitive
prostate cancer.
36 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

37. AIM
To compare the clinical benefit of abiraterone
acetate plus prednisone with placebo plus
prednisone in patients with metastatic castration-
resistant prostate cancer (CRPC) who have failed
one or two chemotherapy regimens.
At least one of the previous chemotherapies must
have contained docetaxel.
DURATION
2008-2012.

COU AA 301
Trial
Abiraterone Acetate
in Castration-
Resistant Prostate
Cancer Previously
Treated With
Docetaxel-Based
Chemotherapy
37 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

38. OVERALL
SURVIVAL
38 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

39. CONCLUSION
Abiraterone acetate significantly prolongs overall survival in patients with metastatic
castration-resistant prostate cancer who have progressed after docetaxel treatment.
39 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

40. OBJECTIVE
To determine whether dutasteride reduces the risk of
incident prostate cancer, as detected on biopsy,
among men who are at increased risk for the
disease.
DURATION
2003 - 2009.

REDUCE Trial
REduction by
DUtasteride of
prostate Cancer
Events
40 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

41. CONCLUSION
Over the course of the 4-year study
period, dutasteride reduced the risk of
incident prostate cancer detected on
biopsy and improved the outcomes
related to benign prostatic
hyperplasia.
41 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

42. AIM
To comparing the safety and efficacy of
XRP6258(Carbazitaxel) plus prednisone to
mitoxantrone plus prednisone in the treatment of
hormone refractory metastatic prostate cancer
previously treated with a Taxotere® (Docetaxel)-
containing regimen.
DURATION
2007-2009.
TROPIC Trial
XRP6258
(Cabazitaxel) Plus
Prednisone
Compared to
Mitoxantrone Plus
Prednisone in
Hormone
Refractory
Metastatic Prostate
Cancer
42 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

43. CONCLUSION
Cabazitaxel prolongs OS at 2 years versus mitoxantrone and has low rates of
peripheral neuropathy.
Palliation benefits of cabazitaxel were comparable to those of mitoxantrone.
43 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

44. AIM
To demonstrate the superiority of cabazitaxel plus
prednisone versus docetaxel plus prednisone in term
of overall survival (OS) in participants with
metastatic castration resistant prostate cancer
(mCRPC) and not previously treated with
chemotherapy.
DURATION
2011-2013.
FIRSTANA
Trial
Cabazitaxel Versus
Docetaxel Both
With Prednisone in
Patients With
Metastatic
Castration Resistant
Prostate Cancer
44 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

45. CONCLUSION
C20 and C25 did not demonstrate superiority for OS versus D75 in patients with
chemotherapy-naïve mCRPC.
Tumor response was numerically higher with C25 versus D75; pain PFS was
numerically improved with D75 versus C25.


Cabazitaxel 20 mg/m
2
(C20)
Cabazitaxel 25 mg/m
2
(C25)
Docetaxel 75 mg/m
2
(D75)
45 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

46. AIM
To compare the clinical benefit of Enzalutamide
versus placebo in patients with castration-resistant
prostate cancer who have been previously treated
with docetaxel-based chemotherapy.
DURATION
2009-2010.
AFFIRM Trial
Safety and Efficacy
Study of
Enzalutamide in
Patients With
Castration-
Resistant Prostate
Cancer Who Have
Been Previously
Treated With
Docetaxel-based
Chemotherapy
46 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

47. CONCLUSION
In addition to improving overall survival, enzalutamide improves wellbeing and everyday
functioning of patients with metastatic castration-resistant prostate cancer.
47 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

48. OBJECTIVE
To determine the benefit of enzalutamide versus
placebo as assessed by overall survival and
progression-free survival in patients with progressive
metastatic prostate cancer who have failed
androgen deprivation therapy but not yet received
chemotherapy.
DURATION
2010-2019.

PREVAIL Trial
Enzalutamide in Men
with Chemotherapy-
naïve Metastatic
Castration-resistant
Prostate Cancer

48 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

49. CONCLUSION
Enzalutamide provided clinically significant benefits in men:
with chemotherapy-naive metastatic castration-resistant prostate cancer,
with or without visceral disease,
low- or high-volume bone disease, or lymph node only disease.
49 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

50. AIM
To determine the efficacy and safety of oral
enzalutamide compared to bicalutamide in castrate
men with metastatic prostate cancer who have
progressed while on Luteinizing Hormone Receptor
Hormone (LHRH) agonist/antagonist or after
receiving a bilateral orchiectomy.
DURATION
Study started in 2011.
Estimated completion in 2017.
TERRAIN
Trial
Efficacy and Safety
Study of
Enzalutamide Versus
Bicalutamide in
Castrate Men With
Metastatic Prostate
Cancer
50 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

51. PROGRESSION
FREE SURVIVAL
51 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

52. PROGRESSION
EVENTS
52 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

53. CONCLUSION
Enzalutamide is a more effective treatment than bicalutamide for patients with
metastatic prostate cancer who progress on ADT.
TERRAIN trial support the use of enzalutamide rather than bicalutamide in patients
with asymptomatic or mildly symptomatic metastatic castration-resistant prostate
cancer.
53 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

54. AIM
To determine the safety and efficacy of
enzalutamide vs bicalutamide in asymptomatic or
mildly symptomatic patients with prostate cancer
who have disease progression despite primary
androgen deprivation therapy.
DURATION
2012-2018
STRIVE
Trial
Safety and Efficacy
Study of
Enzalutamide Versus
Bicalutamide in Men
With Prostate Cancer
54 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

55. PROGRESSION
FREE SURVIVAL
55 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

56. CONCLUSION
Enzalutamide significantly reduced risk of prostate cancer progression or death
compared with bicalutamide in patients with nonmetastatic or metastatic CRPC.
56 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

57. AIM
To determine if the addition of apalutamide to ADT
provides superior efficacy in improving radiographic
progression-free survival (rPFS) or overall survival (OS) for
participants with mHSPC.
DURATION
Study started in 2015.
Estimated completion in 2021.

TITAN Trial
A Study of
Apalutamide Plus
Androgen
Deprivation
Therapy (ADT)
Versus ADT in
Participants With
mHSPC (TITAN)

57 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

58. AIM
To evaluate the efficacy and safety of apalutamide in
adult men with high-risk non-metastatic castration-resistant
prostate cancer.
DURATION
Study started in 2013.
Estimated completion in 2022.

SPARTAN
Trial
A Study of
Apalutamide (ARN-
509) in Men With
Non-Metastatic
Castration-
Resistant Prostate
Cancer (SPARTAN)

58 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

59. METASTASIS
FREE SURVIVAL
59 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

60. CONCLUSION
Among men with nonmetastatic castration-resistant prostate cancer, metastasis free
survival and time to symptomatic progression were significantly longer with
apalutamide than with placebo.
60 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

61. AIM
To assess the efficacy of Sipuleucel-T
Immunotherapy for Castration-Resistant Prostate
Cancer.
DURATION
2012-2017.

IMPACT
Trial
Sipuleucel-T
Immunotherapy for
Castration-
Resistant Prostate
Cancer
61 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

62. PRIMARY
EFFICACY
62 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

63. DOCETAXEL
EFFECT
63 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

64. CONCLUSION
The use of sipuleucel-T prolonged overall survival among men with metastatic
castration-resistant prostate cancer.
No effect on the time to disease progression was observed.
64 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

65. AIM
To compare, in patients with symptomatic hormone
refractory prostate cancer (HRPC) and skeletal
metastases, the efficacy of best standard of care
plus Radium-223 dichloride versus best standard of
care plus placebo, with the primary efficacy
endpoint being overall survival (OS).
DURATION
2008-2014.
ALSYMPCA
Trial
ALpharadin in
SYMPtomatic
Prostate CAncer
65 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

66. CONCLUSION
Radium-223 should be considered as a treatment option for patients with castration-
resistant prostate cancer and symptomatic bone metastases.
66 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

67. AIM
To study how well giving radiation therapy together
with androgen deprivation therapy works in treating
patients who have undergone surgery for prostate
cancer.
DURATION
Study started in 2007.
Estimated completion in 2021.
RADICALS
Trial
Radiotherapy and
Androgen
Deprivation in
Combination After
Local Surgery
67 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

68. AIM
To compare Adjuvant Radiotherapy (RT) With Early
Salvage RT in Patients With Positive Margins or
Extraprostatic Disease Following Radical
Prostatectomy.
DURATION
Study started in 2009.
Estimated completion in 2026.
RAVES Trial
Radiotherapy -
Adjuvant Versus
Early Salvage
68 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

69. AIM
To assess the safety and efficacy of stereotactic
ablative radiotherapy (SABR) for hormone-sensitive
oligometastatic prostate adenocarcinoma, and
To describe the biology of the oligometastatic state
using immunologic, cellular, molecular, and functional
imaging correlates.
DURATION
Study started in 2016.
Estimated completion in 2022.
ORIOLE
Trial
Observation Versus
Stereotactic
Ablative RadiatIOn
for OLigometastatic
Prostate CancEr
69 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

70. AIM
To assess the benefit of Metastasis Directed Therapy
(MDT - surgery or stereotactic body radiotherapy)
for oligorecurrent prostate cancer (PCa).
DURATION
2012-2017.

STOMP
Trial
Salvage Treatment
or Active Clinical
Surveillance for
Oligometastatic
Prostate Cancer
70 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

71. ADT FREE
SURVIVAL
71 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

72. CONCLUSION
ADT-free survival was longer with MDT than with surveillance alone for oligorecurrent
PCa, suggesting that MDT should be explored further in phase III trials.
72 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

73. AIM
To compare Radical Prostatectomy or Watchful
Waiting in Early Prostate Cancer
DURATION
1989-1999.

SPCG 4
Trial
Scandinavian
Prostate Cancer
Group Study
Number 4
73 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

74. CONCLUSION
Extended follow-up confirmed a substantial reduction in mortality after radical
prostatectomy.
74 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

75. AIM
To document the impact of prostate cancer on
resource utilization, clinical outcomes, health-related
quality of life and survival in typical practice
settings. assess the benestate cancer (PCa).
DURATION
Initiated in 1995.

CapSURE
Study
Cancer of the
Prostate Strategic
Urologic Research
Endeavor
75 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

76. AIM
To assess Multi-parametric magnetic resonance
imaging (MP-MRI) used as a triage test might
allow men to avoid unnecessary TRUS-biopsy
and improve diagnostic accuracy.
DURATION
2012-2015.
PROMIS
Study
PROstate MR
Imaging Study
76 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

77. PROMIS STUDY - CONCLUSION
TRUS-biopsy performs poorly as a diagnostic test for clinically significant
prostate cancer.
MP-MRI, used as a triage test before first prostate biopsy, could identify a
quarter of men who might safely avoid an unnecessary biopsy and might
improve the detection of clinically significant cancer.

77 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

78. AIM
To efficacy of the treatment of Pathologic Stage C
Carcinoma of the Prostate with Adjuvant
Radiotherapy.
DURATION
1988-1997.

SWOG 8794
Trial
South West
Oncology Group
8794
78 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

79. CONCLUSION
Adjuvant radiotherapy after radical prostatectomy for a man with pT3N0M0
prostate cancer significantly reduces the risk of metastasis and increases survival.
79 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

80. AIM
To compare Adjuvant Radiotherapy Versus “Wait
and See” in Patients With pT3 Prostate Cancer
Following Radical Prostatectomy.
DURATION
1988-1997.

ARO 96-02
Trial

80 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

81. CONCLUSION
Compared with Wait and See, Adjuvant Radiation Therapy reduced the risk of
(biochemical) progression with a hazard ratio of 0.51 in pT3 PCa.
With only one grade 3 case of late toxicity, ART was safe.
81 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

82. LANDMARK TRIALS IN RCC
ASSURE Trial (Sunitinib, Sorafenib and Placebo)
STRAC Trial (Sunitinib and Placebo)
PROTECT Trial (Pazopanib and Placebo)
TARGET Trial (Sorafenib and Placebo)
COMPARZ Trial (Sunitinib and Pazopanib)
CALGB 90206 (Bevacizumab + Interferon and
Interferon)
AVOREN (Bevacizuman+ Interferon and
Interferon)
CABOSUN (Cabozantinib and Sunitinib)
AXIS Trial (Axitinib and Sorafenib)
METEOR Trial (Cabozanitib and Everolimus)

Checkmate025 (Nivolumab and Everolimus)
Checkmate214 (Nivolumab+Ipilimumab
and Sunitinib)
IMMotion (Atezolizumab + Bevacizumab
and Sunitinib)
PDIGREE (Nivolumab + Ipilimumab and
Cabozanitib)
JAVELIN Renal 101 Trial (Avelumab +
Axitinib and Sunitinib)


82 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

83. RECENT NAMED TRIALS IN UROTHELIAL CANCER
Keynote045 (Pembrolizumab in patients with locally advanced, metastatic, or
unresectable UC who had progressed on platinum-based chemotherapy or had
recurrence after12 months of chemotherapy)
Checkmate275(Nivolumab in patients with metastatic UC who progressed on a
platinum-based regimen)
IMvigor210(Atezolizumab was studied as a first-line treatment in a group of
chemotherapy-naïve cisplatin-ineligible patients)


83 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.

84. THANK YOU
84 DEPT OF UROLOGY, GRH AND KMC, CHENNAI.