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PROST Ca > Prostate trials > Flashcards

Prostate trials Flashcards

Know the key trials with prostate cancer radiation treatment

1
Q

Tendulkar et al 2016

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Meta-analysis w/ retrospective review
  • Evaluated BCF, DM risk w/ starting salvage therapy at different PSA levels (XRT <66 Gy, >66Gy; nonlinear correlation)
  • Node negative (N0), rising PSA after RALP

-Showed benefit when starting salvage at a lower PSA, PSA 0.01 - 0.20 most benefit; roughly 50% drop in benefits if you waited to treat after PSA > 2.0

@5 yr BCF, 10 yr DM; Includes nomogram

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2
Q

RTOG 9601

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Prospective
  • Salvage 64.8 Gy +/- 24 months ADT (bicalutamide)
  • pT2 to pT3 w/ increasing postop PSA >0.2, node negative (N0)

@12 yrs OS w/ ADT 76% (vs 71%)
@12 yrs DM w/ ADT 14% (vs 23%)

  • Subgroup analysis showed ADT benefit mostly in:
  • Positive margins
  • PSA >0.7
  • GS 7
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3
Q

GETUG 16

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Prospective
  • Salvage 66 Gy +/- 6 months ADT (goserelin)
  • pT2-4a (bladder neck only)

@5 yrs PFS w/ ADT 80% (vs 62%)
@5 yrs no difference in OS

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4
Q

SWOG 8794

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Prospective
  • Adjuvant XRT 60 Gy
  • pT3N0, not required to have undetectable PSA

-Adj XRT increased PSA relapse free survival (HR 0.43) and decreased risk of starting ADT (HR=0.45)

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5
Q

EORTC 22911

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Prospective
  • Adjuvant XRT 50 Gy/25 fx to prostate w/ 10 Gy/5 fx boost to tumor

-pT2-pT3N0

@10 yrs, Adj XRT improved BCF rates; 39·4% vs 61·8%
-No significant difference in rate of distant metastasis, overall survival, or prostate cancer specific mortality

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6
Q

ARO 9602

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Prospective
  • Adjuvant XRT 60 Gy
  • pT3N0, postop undetectable PSA

@5 years 18% improvement in BCF-survival w/ adjuvant XRT

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7
Q

RTOG 9408

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized prospective
  • WPRT 46.8 Gy + 19.8 Gy Prostate boost (66.6 Gy) +/- 4 months ADT (neoadj, concurrent)
  • Intermediate risk

@10 yrs OS w/ ADT 62% (vs 57%)

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8
Q

D’Amico 2008

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized prospective
  • XRT (specific dosing unknown) +/- 6 months ADT
  • Intermediate risk

@8 years OS w/ ADT 75% (vs 60%)
-Hazard Ratio 4 for prostate cancer specific mortality w/o ADT

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9
Q

RTOG 9202

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized prospective
  • XRT (50 Gy WPRT + 70 Gy prostate) + (4 months vs 24 months ADT)
  • High risk, some intermediate risk prostate

@10 yrs no difference in OS for intermediate or high risk
@10 yrs, DFS w/ LT-ADT in high risk pts 22% (vs 13% in ST-ADT)

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10
Q

EORTC 22961

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized prospective
  • XRT (50 Gy WPRT + 70 Gy prostate) + (6 months vs 36 months ADT)
  • High risk, some intermediate risk prostate

@5 yrs OS w/ LT-ADT 85% (vs 50% in ST-ADT)

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11
Q

DART 01/05

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized prospective
  • XRT (3DCRT 76-82 Gy) + (4 months vs 24 months ADT)
  • High risk, some intermediate risk prostate

@5 yrs no difference in DFS w/ intermediate risk
@5 yrs DFS w/ high risk LT-ADT 96% (vs 81% on ST-ADT)

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12
Q

NCIC PR 07

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Phase 3 randomized trial
  • XRT (45 Gy pelvis, 65-69 Gy prostate/SV boost) +/- indefinite ADT

Locally advanced:

  • T3 or T4
  • T2 w/ PSA>40
  • T2 w/ PSA>20 and GS >=8

@7 years, difference is OS; 74% vs 66% w/o ADT
@7 years also showed difference in DFS 90% vs 79% w/o ADT

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13
Q

SPCG 7 “Swedish”

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Phase 3 randomized multicenter trial
  • Indefinite ADT (lupron followed by flutamide) +/- XRT (50 Gy pelvis, 70 Gy prostate boost)
  • Locally advanced: T3, PSA <70

@10 years, OS was 70% w/ XRT vs 60%
@10 years, DFS was 75% w/ XRT vs 25%

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14
Q

MD Anderson Dose Escalation; Kuban et al.

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized prospective trial
  • XRT 70 Gy vs 78 Gy to the prostate and SV
  • T1b-T3 N0M0 (80% were T1-T2)

@10 years, prostate specific mortality in high risk patients was was 4% w/ 78Gy vs 16% w/ 70 Gy
@10 years, PSA >10, high risk patients all had differences in BFS, distant metastasis free survival better on 78 Gy arm vs 70 Gy.

NO difference in OS.

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15
Q

PROG 9509

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Prospective, randomized trial
  • XRT 70.2 Gy vs 79.2 Gy to prostate and seminal vesicles.
  • T1b-T2b, PSA <=15 ng/mL
  • 10-year bPFS low-dose 68% vs. high-dose 83%
  • For low-risk disease 72% vs 93%; for intermediate-risk 58% vs. 70%
  • No difference in OS (78% vs 83%)
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16
Q

RTOG 9413

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • High risk patients with estimated risk of LN involvement of 15% or more by the Roach equation and PSA < 100.
  • Pts with T2c-T4 tumors and Gleason >=6 were allowed regardless of LN risk. 2x2 randomization.
  • Randomized to whole-pelvic (WP) vs prostate-only (PO) RT, and combined neoadjuvant + concurrent hormonal therapy (NCHT) vs adjuvant hormonal therapy (AHT).
  • Outcome: PFS WPRT+NHT 62% vs. PORT+NHT 66% vs. WPRT+AHT 69% vs. PORT+AHT 62% (NS); also no difference in OS. By pairs, no difference between WPRT and PORT, and no difference between NHT and AHT. No difference in LF or DM
  • Toxicity: No difference in RT Grade 3+ toxicity among the 4 arms
  • Conclusion: No benefit for NHT + WPRT compared with PORT + AHT
17
Q

GETUG 01

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized. T1b-T3 N0 pNx.
  • WPRT+ Prostate vs. prostate only. RT dose pelvis 46 Gy and prostate 66-70 Gy.
  • Low, Intermediate, High risk. Short term hormonal therapy (6 mos) allowed only for high risk group.
  • 5-year outcome no difference in PFS
18
Q

CHHIP

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Noninferiority
    74 Gy/37 fx in 2.0 per fx vs.
    60 Gy/20 fx in 3.0 per fx vs.
    57 Gy/19 fx in 3.0 Gy per fx
  • 5-yr BF 88.3% vs. 90.6% vs. 85.9%
    60 Gy was noninferior to 74 Gy
    Cannot say 57 Gy is noninferior
  • Hypofractionated radiation in 60 Gy in 20 fractions is noninferior to 74 Gy
19
Q

RTOG 0415

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

20
Q

PROFIT

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • 78 Gy/38 fx vs. 60 Gy/20 fx prostate +/- base of SV
  • Intermediate risk prostate cancer

@5-yr BPFS 85% in both arms
No significant differences in late grade ≥3 GI or GU toxicity

21
Q

King meta-analysis

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

22
Q

ASCEND-RT

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Randomized trial
  • Intermediate or high risk
  • 12 months of ADT and WPRT 46 Gy + LDR brachy boost vs 78 Gy EBRT boost

@9 years Biochemical PFS was 83% w/ LDR vs 62% w/ EBRT boost
@6 years health QOL similar between both groups except for physical and urinary function for brachytherapy group

23
Q

ProtecT

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

24
Q

Toronto

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A

a

  • Trigger point PSADT <3 years, change on clinical exam prompted re-biopsy

@10 year and @15 yr, prostate cancer specific survival 98%, 94% respectively
- 10% of GS 7 had metastatic disease develop compared to 2% in GS <=6

-PSADT and # of positive cores predictors of increased risk of development of metastatic disease

25
Q

PIVOT

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • T1-T2Nx, PSA<50, Age<75, negative bone scan, life expectancy >10 years

40% low risk, 33% medium risk, 22% high risk

  • Mean age 67
  • median PSA 7.8

@19.5 years follow-up:
death in 67% obs vs. 61% surgery, p=0.06
death from cancer or treatment 7.4% vs. 11.4%, p=0.06
Surgery may have led to improved mortality in int risk disease (difference 14.5%)
Surgery did not improve mortality in low or high risk disease

26
Q

STAMPEDE

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • Castration naive prostate cancer, high risk N0M0 disease + 2/3 of following features (T3/T4, PSA >40, or GS 8-10), N1 disease, or M1 disease
  • Mix of high risk, non-metastatic, node-positive, or M1 disease
  • For M1: Abiraterone + prednisone continued until progression.
  • For M0: 2 years of abiraterone + prednisone added on if definative EBRT used
  • OS improved with abiraterone, HR 0.63
  • Decreased survival benefit in men >70 y/o, increased grade 3 cardiac, HTN, hepatic, and renal tox
    Benefit with RT in node positive patients

Survival benefit with docetaxol in locally advanced, N+, and M+ patients

Survival benefit and FFS benefit for abiraterone for metastatic and locally advanced prostate cancer

27
Q

CHAARTED

Trial type:
Trial arms:
Inclusion criteria:
Trial results:

A
  • metastatic prostate cancer
  • six cycles of docetaxel plus ADT vs. ADT alone
  • Median OS 58 mos chemoADT vs. 47 mos ADT

Low volume disease, no OS benefit

-13.6 month OS benefit using upfront docetaxel with ADT compared to ADT alone in men with
hormone naïve metastatic prostate cancer.

-high volume metastatic disease (visceral disease
and/or 4 or more bone metastases including at least one extra-axial metastasis) had a 17 month improvement in median OS (40% reduction in risk of death).

28
Q

ERSPC

European Randomized Study of Screening for Prostate Cancer

A
  • Best approximated proper use of PSA for early detection
  • 1:1 randomization of 20K men, PSA q2 years and threshold for biopsy was PSA >3, PSA >2.5
  • 14 year f/u is the longest
  • Prostate cancer specific mortality 0.5% in screened group, 0.9% in control group (40% absolute cumulative risk reduction of prostate cancer death)
  • 40% of patients initially managed on active surveillence; at 14 year f/u, 28% still were on active surveillance
29
Q

ERSPC and PLCO reanalysis; Tsodikov et al 2017

Prostate, Lung, Colorectal, and Ovarian trial

A
  • Analysis of PLCO and ERSPC trials taking in to account those who were actually screened vs. not and lead time bias. Cox regression analysis
  • Screening estimated to give 7-9% reduction in PCSM per year of mean lead time

11-year follow-up
ERSPC: 25-31% relative benefit in PCSM
PLCO: 27-32% relative benefit in PCSM

30
Q

ICELAND

A
  • randomized European trial
  • Locally advanced or biochemically recurrent prostate cancer to continuous or intermittent ADT
  • No difference in rates of BCF, OS, mean PSA levels, adverse events

PROST Ca (3 decks)

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