Radiotherapy from within The Bone For Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Tony Wu. Department of Surgery, Kaohsiung Veterans

男性健康學園 NTU MEN‘S HEALTH ACADEMY – 2015-08-02

Radiotherapy from within The Bone For Patients with Metastatic

Castration-Resistant Prostate Cancer (mCRPC)

Tony Wu.

Department of Surgery, Kaohsiung Veterans General Hospital


Goals of treatment for mCRPC

Improve overall survivalDelay symptomsMaintain quality of life

Frequency and Impact of Skeletal Involvement among Patients with Advanced Cancer

Cancer Type Frequency 5-yr Survival Median SurvivalMyeloma 95%–100% 10% 20 months

Breast 65%–75% 20% 24 months

Prostate 65%–75% 25% 40 months

Lung 30%–40% 2% to < 5% < 6 months

Renal 20%–25%

Bladder 40%

Melanoma 14%–45%

Thyroid 60%

Frequency adapted with permission from Coleman RE. Skeletal complications of malignancy. Cancer. 1997;80(suppl): 1588-1594.Copyright © 2000 American Cancer Society. Reprinted by permission of Wiley-Liss, Inc., a subsidiary of John Wiley & Sons, Inc.1. Mundy GR. Mechanisms of bone metastasis. Cancer. 1997;80:1546-1556. 2. Coleman RE. Skeletal complications of malignancy. Cancer.1997;80:1588-1594. 3. Ginsberg RJ, Vokes EE, Rosenzweig K. Non-small cell lung cancer. In: DeVita VT, Jr Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. Philadelphia: Lippincott Williams & Wilkins; 6th ed. 2001:925-983.

3




Zoledronic acid, denusumab, radium 223


Strontium 89 acts as a calcium mimic targets bone metastases

Ca

Sr

Ba

Ra


First use of strontium-89


Strontium revisited


Slide 8


Slide 13


Slide 14


Radium-223Radium-223 acts

as a calcium mimic

Naturally targets new bone growth in and around bone metastases

Radium-223 is excreted by the small intestine

Ca

Sr

Ba

Ra


Phase I biodistribution study of Radium-223


Radium-223 Dichloride Solution for Injection

◦ Radium-223 is predominantly an α-emitter

◦ t½ = 11.43 days ◦ Of the total decay energy

95.3% emitted as particles 3.6% emitted as particles 1.1% emitted as γ or X-rays

◦ Easily measured on standard instruments (dose calibrators / survey meters)

Radium-223 decay chain1

1. Henriksen et al. Cancer Res 2002;62:3120–5.

b-

1.37 MeV

211Po516 ms

223Ra11.43 d

219Rn3.96 s

215Po1.78 ms

211Pb36.1 m

207Tl4.77 m

211Bi2.17 m

207Pbstable

a5.78 MeV

a6.88 MeV

a7.53 MeV

a6.68 MeV

a6.68 MeV

(99.73%)

(0.27%)

b-

584keV

b-

1.42 keV

Page 20 • Radium-223 Dichloride - Site Training V1.1 • Covance


Why Alpha?

◦ a-particles have a high energy, but short path length - which minimizes damage to healthy tissue surrounding the cancer cells

◦ In contrast, ß-particles - used in bone pain palliation agents produce low-energy radiation and a longer track length

α β

Relative particle mass 7000 1

Initial energy (MeV) 3–8 0.01–2.5

Range in tissue (μm) 40–90 50–5000

LET (KeV/μm) 60–230 0.015–0.4

Charge +2 –1

Ion pairs/μm 2000–7000 5–20

DNA hits to kill cell 1–5 100–1000

Relative biological effectiveness

20 1

The properties of a-emitters allow: Localised cell killing - high

radiation dose in a smaller area Irradiation of a smaller area

and better targeting Minimal non-target toxicity

(e.g. bone marrow)



Slide 25


ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) Phase III Study Design


Bq V.S Ci

Antoine Henri BecquerelThe Nobel Prize in Physics 1903

• The becquerel (symbol Bq) (pronounced: 'be-kə-rel) is the SI derived unit of radioactivity.

• 1 Bq is defined as the activity of a quantity of radioactive material in which one nucleus decays per second.

• The becquerel succeeded the curie (Ci),

an older, non-SI unit of radioactivity based on the activity of 1 gram of radium-226.

1 Ci = 3.7×1010 Bq = 37 GBq

1 μCi = 37,000 Bq = 37 kBq

1 Bq = 2.7×10−11 Ci = 2.7×10−5 µCi

http://en.wikipedia.org/wiki/Radium-226


ALSYMPCA Study EndpointsPrimary Endpoint

◦Overall survival (OS)Secondary Endpoints

◦Time to first SRE◦Time to total ALP progression◦Total ALP response◦Total ALP normalization◦Time to PSA progression◦Safety◦Quality of life


ALSYMPCA OS Analyses

Planned interim analysis (IA)◦ 314 events from 809 patients randomized at the time of the IA;

Cut-off October 2010◦ June 3, 2011 the Independent Data Monitoring Committee (IDMC)

recommended stopping the trial early due to evidence of a significant treatment benefit

Updated analysis◦ 528 events from all 921 patients randomized to the study

◦ Updated analysis conducted prior to placebo patients crossing over to Radium-223 and when Radium-223 patients had completed treatment; Cut-off July 2011


ALSYMPCA Overall Survival


ALSYMPCA Time to First Skeletal-Related Event


ALSYMPCA OS Analyses

Planned interim analysis (IA)◦ 314 events from 809 patients randomized at the time of the IA;

Cut-off October 2010◦ June 3, 2011 the Independent Data Monitoring Committee (IDMC)

recommended stopping the trial early due to evidence of a significant treatment benefit

Updated analysis◦ 528 events from all 921 patients randomized to the study

◦ Updated analysis conducted prior to placebo patients crossing over to Radium-223 and when Radium-223 patients had completed treatment; Cut-off July 2011


ALSYMPCA Updated AnalysisPatient Demographics and Baseline Characteristics (ITT N = 921)

ParameterRadium-223

n = 614Placebon = 307

Age, y Mean 70.2 70.8

Race, n (%) Caucasian 575 (94) 290 (95)

Baseline ECOG score, n (%) ≤ 1 2

536 (87)76 (12)

265 (86)40 (13)

Extent of disease, n (%) < 6 metastases 6–20 metastases > 20 metastases/superscan

100 (16)262 (43)249 (41)

38 (12)147 (48)121 (40)

WHO ladder, cancer pain index ≥ 2, n (%) 345 (56) 168 (55)


ALSYMPCA Updated AnalysisPatient Baseline Characteristics (ITT N = 921)

ParameterMedian (min, max)

Radium-223(n = 614)

Placebo(n = 307)

Haemoglobin, g/dL 12.2 (8.5-15.7) 12.1 (8.5-16.4)

Albumin, g/L 40 (24-53) 40 (23-50)

Total ALP, µg/L 211 (32-6431) 223 (29-4805)

LDH, U/L 315 (76-2171) 336 (132-3856)

PSA, µg/L 146 (3.8-6026) 173 (1.5-14500)

Current bisphosphonates Yes, n (%) 250 (40.7) 124 (40.4)

Prior docetaxel Yes, n (%) 352 (57.3) 174 (56.7)


ALSYMPCA Updated AnalysisPatient Disposition

Radium-223N = 614

PlaceboN = 307

Patients treated, n 599 302

Median number of injections, range

6 (1-6) 5 (1-6)

Received all 6 injections, n (%) 387 (63) 145 (47)





ALSYMPCA Updated Analysis: Radium-223 Improved OS Across All Patient Subgroups

SUBGROUP

PATIENTS (n) MEDIAN OS (months)

HR 95% CIRADIUM-

223 PLACEBORADIUM-

223 PLACEBO

All patients 614 307 14.9 11.3 0.70 0.58-0.83

Total ALP<220 U/L 348 169 17.0 15.8 0.82 0.64-1.07

≥220 U/L 266 138 11.4 8.1 0.62 0.49-0.79Current use of bisphosphonates

Yes 250 124 15.3 11.5 0.70 0.52-0.93

No 364 183 14.5 11.0 0.74 0.59-0.92

Prior use of docetaxelYes 352 174 14.4 11.3 0.71 0.56-0.89

No 262 133 16.1 11.5 0.74 0.56-0.99

Baseline ECOG PS0 or 1 536 265 15.4 11.9 0.68 0.56-0.82

≥2 77 41 10.0 8.4 0.82 0.50-1.35

Extent of disease<6 Metastases 100 38 27.0 NE 0.95 0.46-1.95

6-20 Metastases 262 147 13.7 11.6 0.71 0.54-0.92

>20 Metastases 195 91 12.5 9.1 0.64 0.47-0.88

Superscan 54 30 11.3 7.1 0.71 0.40-1.27

Opioid useYesa 345 168 13.9 10.4 0.68 0.54-0.86

Nob 269 139 16.4 12.8 0.70 0.52-0.93FavorsRadium-223

FavorsPlacebo

ALP, alkaline phosphatase; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HR, hazard ratio.a. Includes patients with a score of 2 or 3 on the World Health Organization (WHO) ladder for cancer pain. b.Includes patients without pain or opioid use at baseline and patients with a score of 1 on the WHO ladder for cancer pain.SOURCE: Parker C, et al. N Engl J Med. 2013;369(3):213-23.

0.5 2.01.0

37


39

SSE (ALSYMPCA) SRE

Symptomatic Skeletal Event Skeletal Related Event

Definition Spinal cord compression Spinal cord compression

Tumor-related orthopedic Surgical intervention

Surgery to bone

New symptomatic pathological fractures

Pathological fractures

Use of EBRT to relieve skeletal symptoms

Radiation therapy to bone

Hypercalcemia of malignancy

Characteristics No regular radiologic image and more clinical relevant


Time to 1st Symptomatic Skeletal Event, By Baseline Stratification Factors

5.7 mon

2.5 mon

6 mon 6.2 mon


Time to 1st Symptomatic Skeletal Event, By Baseline Stratification Factors

9.4 mon

3.4 mon


Relative Risk Of Individual Symptomatic Skeletal Event components


ZA delayed first SRE in bone metastatic CRPC

Every 3~4 weeks

Adapted from Saad F, et al. Eur Urol Suppl. 2007;6(11):683-688.

(16.3 mons)

(10.7 mons)


Denosumab vs. ZA: time to first on-study SRE

Fizazi K, et al. Lancet. 2011;377:813-822.

3.6 mons

ALSYMPCA Updated AnalysisSecondary Endpoints: ALP and PSA

Radium-223n (%)

Placebon (%)

P value

Total ALP response 30% reduction 50% reduction

233 (47)135 (27)

7 (3)2 (<1)

<0.001 <0.001

Total ALP normalization*

109 (34) 2 (1) < 0.001

*In patients who had elevated total ALP at baseline.

Hazard ratio 95% CI

P value

Time to Total ALP progression

0.167 (0.129, 0.217)

<0.00001

Time to PSA progression 0.643

(0.539, 0.768) <0.00001


Ra-223 early access program (EAP)

phase 2 prospective, interventional, open-label, multicenter study

42% had improved pain—a decrease of ≧ 2 in BPI-SF scores without worsening;

18% had stable pain or decrease of < 2 points28% had worsening pain—an increase of ≧ 2

points or initiation of opioids—and never had improvement in pain.

10% experienced both improvements and worsening of pain at different times during treatment with Ra-223.

Christopher Sweeney, 2015 ASCO

ALSYMPCA Updated AnalysisAEs of Interest

All Grades Grades 3 or 4

Patients with AEs n, (%)

Radium-223n = 600

Placebon = 301

Radium-223n = 600

Placebo n= 301

Hematologic

Anemia 187 (31) 92 (31) 77 (13) 39 (13)

Neutropenia 30 (5) 3 (1) 13 (2) 2 (1)

Thrombocytopenia 69 (12) 17 (6) 38 (6) 6 (2)

Non-Hematologic

Bone pain 300 (50) 187 (62) 125 (21) 77 (26)

Diarrhea 151 (25) 45 (15) 9 (2) 5 (2)

Nausea 213 (36) 104 (35) 10 (2) 5 (2)

Vomiting 111 (19) 41 (14) 10 (2) 7 (2)

Constipation 108 (18) 64 (21) 6 (1) 4 (1)

Safety of Cytotoxic Chemotherapy Following Rd-223 Therapy

Number of deaths and causality during 30 days post Chemo and limited available hematologic data were similar in both groups

2012 ESMO

1.5-Year Posttreatment Follow-up <br />of Radium-223 Dichloride (Radium-223) <br />in Patients With Castration-Resistant Prostate Cancer (CRPC) and <br />Bone Metastases From the <br />Phase 3 ALSYMPCA Study

Presented By Sten Nilsson at 2014 Genitourinary Cancers Symposium

ALSYMPCA Long-term Follow-Up


Conclusions



Optimal timing of ra-223

No clear data suggesting that treatment earlier or later with radium-223 is ideal.

if ra-223 is used after failure of abiraterone or enzalutamide, fewer men complete ≧4 cycles of therapy.

Prolonged overall survival was associated with receipt of 5 to 6 versus 1 to 4 ra-223 injections,

radium-223 can be safely given concurrently with other treatments, including enzalutamide, abiraterone acetate, and even docetaxel.

Tanya Dorff. 2015 ASCOEarly use


Optimal timing of ra-223

If used too early, patients may not experience profound reduction in pain

If used later, the treatment can have a more profound effect due to the greater disease burden in the bone.

Later use may ultimately lead to greater uptake and delivery of radium to the bone due to more areas of bone turnover and drug incorporation.

Tanya Dorff. 2015 ASCO

Late use


ALSYMPCA AP in Taiwan

◦National Taiwan University Hospital, ◦Taipei Veterans General Hospital, ◦Taipei Chang-Gung Memorial Hospital◦Kaohsiung Veterans General Hospital,

◦16 mCRPC patients


Gleason ADT response

Time to mCRPC

Tx. after CRPC

CRPC to Ra 223

Ra 223 dose

KS03 3+4 Good 25 Tasq. 63 6

KS04 2~6 Good 67 Docet 84 5

KS05 8~10 Poor 36 AA 37 6

NTU1 4+3 Poor 19 Docet 10 6

NTU2 9 Good 8 Nil 13 4

NTU4 9 Fair 14 Docet 7 3

NTU5 8 Good 9 Carb+docet 34 6

NTU7 7 Good 23 docet 48 2

TPE4 8~10 Good 9 Docet 55 6

TPE5 8~10 Good 23 Nil 29 6

TPE7 2~6 Good 13 Nil 2 6

TPE8 8~10 Good 50 AA 40 6

CG01 8~10 Good 116 nil 7 6

CG02 8~10 Good 8 Docet 10 4

CG03 4+3 Good 108 AA 6 6

CG05 4+3 Good 22 nil 22 5


PSA response

58

RADIUM-223 PLACEBOP

VALUE

ALSYMPCA≥30% Reduction in PSA blood levels at week 12, %

16 6 <0.001

ALSYMPCA-AP in TW 6 - -

ALSYMPCA ≥30% Reduction in PSA blood levels sustained through end of treatment (4 weeks after last injection), %

14 4 <0.001

ALSYMPCA-AP in TW 0 - -

ALP, alkaline phosphatase; PSA, prostate-specific antigen.SOURCE: Parker C, et al. N Engl J Med. 2013;369(3):213-23.

All Taiwanese patients never have local therapyRadium 223 cannot target prostate gland


ALP / BPI ChangeWBBS C1D1 C2D1 C3D1 C4D1 C5D1 C6D1 EOT

KS03 >20 BPI 3 3 0 3 7 8 9

ALP -51 % -58 % -54% -54 % -62% -62%

KS04 6~20 BPI 9 3 5 0 5

ALP -9% +2 % -12 % -7%

KS05 6~20 BPI 1 0 3 0 0 0 0

ALP -62 % -73% -70 % -64% -55 % -48%

NTU1 >20 BPI 1 1 1 1 4 4 10

ALP -9 % -20 % -23 % +7 % -5% -25 %

NTU2 >20 BPI 9 9 9 8 9

ALP -1 % +63% +66% +244 %

NTU4 >20 BPI 4 2 1 3

ALP +32% -14% -11%

NTU5 >20 BPI 7 9 6 9 8 7 9

ALP -31 % -22 % -10 % -7% -7 % -29%

NTU7 >20 BPI 10 9 6

ALP +13 % -33 %


ALP / BPI ChangeWBBS C1D1 C2D1 C3D1 C4D1 C5D1 C6D1 EOT

TPE4 6~20 BPI 6 3 8 6 2 4 2

ALP -25 % -33% -31% -41 % -40 % -40%

TPE5 <6 BPI 4 4 4 2 5 9 7

ALP -26% -32 % -27% -42 % -38 % -39 %

TPE7 >20 BPI 5 5 6 7 4 1 5

ALP -16% -29 % -39% -53 % -71% -71 %

TPE8 <6 BPI 6 6 5 7 4 6

ALP -15 % +1 % -36 % -15 % +115 %

CG01 <6 BPI 6 5 6 5 4 5 0

ALP -6 % -18% -12 % -22 % -22 % -13 %

CG02 >20 BPI 7 6 7 8 8

ALP -35 % -50% -60 % -59 %

CG03 >20 BPI 7 7 5 7 5 5 5

ALP -6 % +2 % -6% -14 % -9% -19%

CG05 >20 BPI 5 5 4 2 0 6

ALP -43% -77% -78 % -73% -47%


61

SECONDARY EFFICACY ENDPOINTS

RADIUM-223

(n = 614)PLACEBO(n = 307)

HAZARD RATIO

(95% CI)P

VALUE

Median time to total ALP progression (months) 7.4 3.8 0.17 (0.13-

0.22)<0.00

1

Total ALP response (≥30% reduction), n (%)a

233/497 (47) 7/211 (3) — <0.00

1

Total ALP normalization, n (%)a,b 109/321 (34) 2/140 (1) — <0.00

1

ALSYMPCA: ALP Response and Normalization

tALP ≥ 30% tALP ≥ 50%0%

10%

20%

30%

40%

50%

60%

44%

31%

50%

20%

total (n=16)Complete treatment (n=10)



Results ... ... ... Pain score. Most patients reported pain palliation. Pain relief, defined as a change in

pain score of >10 (26), was observed in more than half of the patient population, for all time points compared with the baseline. At the 1-week point, 52% reported improvement, 36% unchanged, and 12% worse pain. At the 4-week point, 60% reported improvement, 20% unchanged, and 20% worse pain. At the 8-week point, 56% reported improvement, 24% unchanged, and 20% worse pain. It should be noted that two of the patients had no skeletal pain at baseline and were therefore limited to the unchanged or worse pain categories. No clear dosage response relationship could be observed. A transient increase in bone pain (i.e. a “flare” response) was reported in seven (28%) of the patients during the first week after treatment.

Dose Escalating Phase I study


Initial experience of radium-223 treatment for metastatic castrate resistant prostate cancer in community setting. 2014 ASCO Annual MeetingCitation: J Clin Oncol 32, 2014 (suppl; abstr e16106)

Background: …. Methods: Clinical data from 19 mCRPC patients treated with Ra-223 was collected from a

large multi-disciplinary group. In accordance with the FDA’s recommended dosage, Ra-223’s monthly injections were composed of 1 dose of 50 kBq/kg, for 6 months. Up to the third injection, the World Health Organization’s (WHO) ladder for cancer pain was assessed and the pain pattern evaluated and classified in groups: no or minimal pain relief, worsening and improvement of pain. Also, short-term incidence of side effects was reported together with the hematologic parameters at each injection. Data is expressed as a median (range).

Results: This cohort was composed of 19 Caucasian men aged 74 (53-85) years old, and all suffered bone metastasis. At baseline, 13.3% graded the pain at 1 according to the WHO pain score. At the first follow-up, 27 (19-35) days after the first injection, 21.5% (2/19) noticed pain relief, and 37.5% had a WHO score of 1. 22 (21-22) days after the second injection, 44.4% (8/18) had reduced pain symptoms, and 37.5% had a WHO score of 1. At the third follow-up, 35 (22-35) days after the third injection, 50% (6/12) had pain relief, and 50% had a WHO score of 1. Also, for 10.5% (n=2) of our cohort, pain symptoms worsened while 21% (n=4) reached total pain remission by the third injection. Increased bowl movement frequency was observed in 10.5% of our cohort, diarrhea in 31.6%, constipation in 5.3%, nausea in 26.3%, vomiting in 5.3%, bone pain flair response in 26.3% and lower limb edema in 10.5%.

Conclusions: Our short-term results demonstrated promising bone-pain relief effect of Ra-223 in 50% of our patients even after a maximum of only three injections. Encountered side effects were mild including mostly gastro-intestinal symptoms, but a 21.3% platelet reduction



Adverse Events

Pain: 7(43.8%)Nausea/vomiting: 6(37.5%)Anorexia: 3 (18.8%)Hematuria: 4 (25%)AUR: 2 (12.5%)HypotensionLFT abnormal

Anemia: 4 (25%)WBC decrease: 1 (6.3%)Plt decrease: 2 (12.5%)Septic shock: 1Hypocalcemiahypokalemia


Introduction Product name Radium-223 dichloride solution for injection

Brand (Generic) Name: Xofigo®

Chemical name Radium-223 dichloride (223RaCl2)

Primary indication: Treatment of CR/HR prostate cancer in patients with bonemetastases

Dosage form Sterile, isotonic aqueous solution of radium-223 dichloride

Mode of action Alpha irradiation / ablation of cancer cells

Dosing regimen 6 doses given at 4 week intervals via intravenous injection

Manufacturer: Institute for Energy Technology (IFE), NorwayAlgeta ASA, Norway (for release)

Development status: Approval by the US FDA in May 2013, approval in Europe in Nov 2013



Radium-223 Dichloride Solution for Injection

◦ A standardized, stable, vial-based product that is easy to use ◦ Ready to use, direct injection via syringe

- No generators/elutions required - No kit preparation, no chelating to targeting agent

◦ Glass vial; 6 mL solution ◦ 6 MBq (162 µCi) radium-223 per vial

(at reference date)◦ Radioactivity concentration = 1000 kBq/mL

(at reference date) ◦ Detectable with standard dose calibrators/probes◦ Shelf-life: 28 days◦ No long-lived radioactive waste products after decay*



Dose of Radium-223 Compared with Common RadiopharmaceuticalsRadiopharmaceutical Indication Dose

(MBq)

Ra-223 Dichloride Bone metastases

3.5

Tc-99m HDP Scintigraphy 740

F-18 FDG PET imaging 300

I-131 Tositumomab NHL 3108

Sm-153 EDTMP Bone pain

2590

Y-90 Ibritumomab tiuxetan

NHL 1184

In comparison, the patient dose of radium-223 dichloride is considerably lower: 3.5 MBq (95 µCi) (70 kg body weight)


Pharmacy and Administration of Radium-223

70

• Ready to use1

• Long shelf life (28 days)

• Ready to use1

• Long shelf life (28 days)

• One visit per dose• IV injection• Outpatient treatment2

• One visit per dose• IV injection• Outpatient treatment2

1. Nilsson et al. Presented at: American Society for Radiation Oncology annual meeting 2010; poster 2385. 2. Biggin. Eur J Nucl Med Mol Imag. 2007;34:S391 Abstract P646.


ALYSMPCA Updated Analysis ConclusionsRadium-223 compared with placebo in CRPC

patients with bone metastases:◦ Significantly prolonged median OS by 3.6 months

(HR = 0.695; P = 0.00007) 30.5% reduction in risk of death

◦ Significantly prolonged median time to first SRE by 5.5 months

(HR = 0.64; P < 0.0001)

Further follow-up in all randomized patients continues to show highly favorable safety profile


Ra-223 showed significantly better preservation of QOL, with improved functioning and well-being, compared to Placebo

Similar safety profiles were observed in patients who received chemo after Ra-223 and in those who received chemo after placebo

ALYSMPCA Updated Analysis Conclusions


Ra-223 ongoing studies with combination regimen

73

Combination study Patient Phase Primary endpoint

Ra223 + Abiraterone Acetate mCRPC II Bone pain assessment & QoL

Ra223 + Abiraterone Acetate V.SPlacebo + Abiraterone Acetate

Pre-chemo III Symptomatic skeletal event free survival (SSE-FS)

Ra223 + Docetaxel V.S Docetaxel mCRPC I, II Dose escalation: ToxicityExpanded cohort: Safety

Ra223 +Enzalutamide mCRPC II Safety

Ra223 +Enzalutamide mCRPC II Bone formation markers at W11, 19, and 26

Ra223 V.S Ra223 + Abiraterone Acetate or Enzalutamide

mCRPC IIa Bone scan response at W24


Ongoing trial in Taiwan

International, multicenter, randomized, open-label phase II study.

3 treatment arms in 1:1:1 fashion: ◦50 kBq/kg IV every 28 days for up to 6 doses ◦80 kBq/kg IV every 28 days for up to 6 doses ◦50 kBq/kg IV every 28 days for up to 12 doses


Thanks For Your Attention

Documents

Radiotherapy from within The Bone For Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Tony Wu. Department of Surgery, Kaohsiung Veterans