Document 6480470

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Document 6480470

This practice algorithm has been specifically developed for M. D. Anderson using a multidisciplinary approach and taking into consideration circumstances particular to M. D. Anderson,
including the following: M. D. Anderson’s specific patient population; M. D. Anderson’s services and structure; and M. D. Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers.
Note: Consider Clinical Trials as treatment options for eligible patients.
This Prostate Cancer treatment consensus algorithm is used as a framework for the application of individualized therapy for patients with prostate cancer at the M.D.
Anderson Cancer Center. The faculty and members of the Genitourinary Center apply this general algorithm to individual patients accommodating patient preference
and physician experience in the context of a specific knowledge of prostate cancer.
Copyright 2012 The University of Texas M.D. Anderson Cancer Center
Department of Clinical Effectiveness V9
Approved by Executive Committee of the Medical Staff 06/26/2012
STAGING WORKUP
INITIAL DIAGNOSIS
PRESENTING
CLINICAL STAGE
cT1a
Prostate biopsy1
DRE
PSA
Gleason score
Life expectancy greater
than or equal to 5 years,
or symptomatic from
local or metastatic
disease
Life expectancy less
than 5 years and
asymptomatic
Follow up annually, no
further work up until
symptoms, for example,
bone pain or voiding
dysfunction
Bone scan if:
● PSA greater than 15 ng/mL or
● cT3-cT4 disease or
● Bone pain or
● Positive nodes on CT/MRI imaging or
● Gleason scores of 8-10 or
● Adverse histologies (e.g. small cell and/or
neuroendocrine)
● CT or MRI considered for high risk patients
based on NCCN guidelines2
FNA if clinically indicated
See Page 3 of
this algorithm
cT1b, cT1c, cT2a, cT2b
cT3a
cT3b, cT4
Any T N1, M0
See Page 4 of
this algorithm
Any T or N, M1
Symptomatic
Any N M1 with
Visceral or lytic bone
metastases and low
PSA
1
Perform prostate biopsy if not previously done. If done, MDACC review of prostate
biopsy results.
2
http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf
PRESENTING
CLINICAL STAGE Life expectancy less
than 10 years
cT1a
Life expectancy
greater than or
equal to 10 years
TRUS
biopsy
INITIAL THERAPY
TRUS biopsy if
Gleason score 8-10
Not reclassified to
higher risk
Reclassified to
higher risk
Low Risk Disease:
cT1-cT2a and
PSA less than 10 ng/mL
and Gleason score 2-6
Monitor patient for symptoms; consider treatment if progression
Active surveillance or
1
2
● Consider external beam radiotherapy or Brachytherapy
1
● Radical prostatectomy if life expectancy greater than 20 years
●
Consider treatment based on new stage
Active suveillance
2
● Brachytherapy
2,5
● Cryotherapy
●
External beam radiation3
4
● Radical Prostatectomy
●
Brachytherapy2 (on protocol)
5
● Cryotherapy
● External beam radiation with 4-6 months adjuvant androgen
ablation (See Box B, Page 6)
● Active surveillance (on protocol)
●
cT1b
TRUS
biopsy
Yes
cT1c, cT2a,
cT2b
Life
expectancy
greater than or
equal to 10
years?
Intermediate Risk Disease:
cT2b (but not qualifying for
high risk disease) or
PSA 10-20 ng/mL or
Gleason score 7
High Risk Disease:
cT2c-cT3a or
PSA greater than 20 ng/mL or
Gleason score 8-10
See Page 7 for
appropriate follow up or
active surveillance
based on initial therapy
See Page 7 for
appropriate active
surveillance based on
initial therapy
Cryotherapy5
● External beam radiation with 2-3 yesrs adjuvant
androgen ablation (See Box B, Page 6)
●
Locally Advanced – See Page 4
No
1
Monitor patient for symptoms; consider treatment if progression or
1
● Consider external beam radiotherapy or cryoablation or hormonal ablation (See Box B, Page 6)
●
All localized treatments: length of follow-up and quality of data differ with each treatment and should be discussed with your treatment team
Brachytherapy and cryotherapy eligibility limited by prostate size, pubic bone geometry, baseline urinary function
3
External beam radiation should be dose escalated using either IMRT (intensity modulated radiation therapy), or proton therapy. Inflammatory bowel Disease and peri-rectal disease may be contraindications.
4
Radical prostatectomy is performed by open retropubic or robot assisted technique. These technique choices, eligibility for a nerve sparing procedure, and the need for a pelvic lymph node dissection should be discussed
with your treatment team.
5
External beam radiation and Brachytherapy radical prostatectomy have longer duration of follow-up and may be preferred over cryotherapy
2
PRESENTING
CLINICAL STAGE
INITIAL THERAPY
External beam radiotherapy with androgen ablation1, 3 or
3
● Androgen ablation (See Page 6, Box B) or
● Consider radical prostatectomy in selected cases or on protocol
●
Locally Advanced
(cT3a, cT3b, cT4)
Any T N1
Life
Expectancy
greater than or equal
to 5 years or
symptomatic?
1
2
3
Favorable
clinical
response
Consider:
● Radiotherapy or
● Consider radical prostatectomy or
● Clinical trial
Yes
Consider 6-12 months
androgen ablation
No
Consider androgen ablation 3 (See Page 5 or 6)
PSA every 3 months,
Radiographic studies if
clinically indicated
(bone scans, CT of
abdomen and pelvis)
Androgen ablation 3 (See Page 5 or 6)
Any T or N M1
Any N, M1 with
visceral or lytic
bone metastases
and low PSA
FOLLOW UP
Biopsy
metastatic
lesions
Pathology shows
Small Cell
component and/or
neuroendocrine
markers
Cisplatin and Etoposide or
Clinical Trial or
● Palliative Care
●
●
3D conformal radiotherapy or intensity modulated radiotherapy (IMRT) are standard for external beam radiotherapy.
Based on pathologic findings after radical prostatectomy (e.g. path stage, margin status, Gleason score, age), consider adjuvant external beam radiotherapy.
Treatment recommendation is dependent of life expectancy. See Page 6.
ANDROGEN
ABLATIVE
THERAPY
FOLLOW-UP
ANDROGEN-INDEPENDENT SALVAGE THERAPY
●
A
Intermittent
androgen
ablation1
Follow up visit every 3
months with PSA and
testosterone, repeat imaging if
rising PSA and/or clinical
progression, and liver
function tests every month for
3 months if on antiandrogens.
If on anti-androgen alone, add LHRH agonist; if progression, go to Box D on page 6
If on LHRH agonist alone, switch to continuous androgen ablation and add
anti-androgen; if progression, go to Box C on Page 6
Yes
●
No
Continue follow up and current treatment
Rising PSA or
other signs of
progression?
Progression
For Continuous Androgen
Ablation, see Box B on Page 6
1
Consider intermittent androgen ablation for rising PSA only. If skeletal metastases are present, recommend 7 to 14 days of antiandrogen prior to
initiation of LHRH agonist to prevent flare.
2
Consider baseline bone density scan and bisphosphonate therapy every 6 months to minimize osteoporosis associated with LHRH agonist use.
3
Check Liver Function Tests 1 month after initiation of antiandrogen and then with each 3 month follow up visit thereafter.
ANDROGEN
ABLATIVE
THERAPY
B
Continuous androgen
ablation with LHRH
agonist alone1, 2 or
with antiandrogen3
ANDROGEN-INDEPENDENT SALVAGE THERAPY
FOLLOW-UP
Follow up visit every
3 months with PSA,
testosterone, repeat
imaging if rising PSA
and/or clinical
progression, liver
function tests every
month for 3 months if
on antiandrogens.
Serum
testosterone
greater than
50?
C
Rising
PSA or other
signs of
progression?
Yes
Yes
Yes
No
Chemotherapy (Docetaxel
and Glucocorticoids) or
● Clinical Trial or
● Supportive care
●
Yes
Progression
No
Progression, go to Box C
D
No
Antiandrogen
given?
Progression with visceral or lytic
bone metastases and low PSA
Yes
Discontinue antiandrogen
Continue
follow up
Decreasing
PSA?
No
No
Continue follow up or
current therapy
For Intermittent
Androgen
Ablation,
see Box A on Page 5
Progression
of
symptoms or by
imaging?
If LHRH agonist and anti-androgen,
consider Orchiectomy or
● If LHRH agonist alone, consider
adding antiandrogen2 orswitch to GnRH
receptor antabgonist
●
Secondary hormone therapies or noncytotoxics
Antiandrogen3 , Diethylstibestrol, Ketoconazole,
Abiraterone, Sipuleucel-T or low dose
Glucorticoids if not previously given
Biopsy
metastatic
lesions
Pathology shows
Small Cell component
and/or neuroendocrine
markers
Cisplatin and Etoposide or
● Palliative Care
●
Clinical Trial or
● Bone-targeting radio● Palliative radiotherapy or
isotopes such as Strontium or
● Salvage chemotherapy or ● Supportive care
3
● Secondary hormone therapies or noncytotoxics Antiandrogen ,
Diethylstilbestrol, Ketoconazole, Abiraterone, Sipuleucel-T
or low dose Glucorticoids if not previously given
●
Progression without visceral or
lytic bone metastases and low PSA
Secondary hormone therapies or noncytotoxics Antiandrogen3,
Diethylstilbestrol, Ketoconazole, Abiraterone, Sipuleucel-T or
● Low-dose Glucocorticoids if not previously given or
● Observation
●
1
If skeletal metastases are present, recommend 7 to 14 days of antiandrogen prior to initiation of LHRH agonist to prevent flare.
Consider baseline bone density scan and bisphosphonate therapy every 6 months to minimize osteoporosis associated with LHRH agonist use.
3
Check Liver Function Tests 1 month after initiation of antiandrogen and then with each 3 month follow up visit thereafter.
2
PATIENT STATUS
Consider active surveillance protocol
PSA and DRE every 6 months
● TRUS biopsy at baseline and annually (option
to skip years if 1-2 negative biopsies in a row)
● Consider active surveillance support group
●
●
Patient on active surveillance
PROGRESSION
ACTIVE SURVEILLANCE
PSA trend and/or repeat biopsy indicates
reclassification to higher risk, or
symptomatic, or unable to tolerate further
biopsies
Refer to appropriate stage on
Pages 3 or 4 of this guideline
FOLLOW UP
(Continue monitoring until progression)
Patient post definitive therapy
(i.e. radiotherapy or radical
prostatectomy)
Symptom evalation
PSA every 3-6 months for 5 years,
then every 6-12 months for 5 years,
then annually
After radiotherapy:
DRE every 6-12 months
After radical prostatectomy:
DRE every 1-3 years with
follow-up visit
Yes
Signs
of recurrence or
progression?
No
See Page 8 for Recurrent Prostate Cancer
Patient
5 or more years
From
Treatment?
Yes
Transfer to Survivorship Clinic
No, continue
monitoring
Status post radical
prostatectomy with positive
surgical margins and/or
pT3a or b, and Nx/N0,
PSA undetectable after
surgery
Consider randomized clinical trials supporting
the long-term survival benefits of adjuvant
radiation weighed against the side effects
RECURRENCE
PROGRESSION
SALVAGE THERAPY
Yes
Androgen ablation (See Page 5 for
intermittent or Page 6 for continuous)
Consider prostatectomy or
Cyoablation or
● Radio-isotopic implant
● Androgen ablation
● Observation
●
Bone scan, abdominal
and pelvic CT
Patient presents after
surgery or radiation
with positive DRE or
increasing PSA1
Bone scan
and CT scans
positive?
●
Yes
No
PostRadiotherapy
Consider
prostate
biopsy
Biopsy
positive?
No or
not done
Observation
●
Post-radical
Prostatectomy
Bone scan, abdominal and pelvic CT, TRUS
Consider prostate bed biopsy
Consider Prostascint scan with co-registration
Bone scan
and CT scans
positive?
Yes
No
Androgen ablation (See Page 5 for
intermittent or Page 6 for continuous)
Observation
2
● External beam radiotherapy or
●
1
Rising PSA after radical prostatectomy is greater than 0.2 ng/mL
Rising PSA after radiotherapy or brachytherapy is PSA greater than 2 .0 ng/mL above the nadir
(lowest value post treatment off androgen deprivation, or medical castration therapy (ADT)
2
Numerous studies indicate that salvage external beam radiotherapy is most effective if delivered
with a PSA less than 0.5 ng/mL
SUGGESTED READINGS
1. Bolla M, Collette L, Blank L, et al. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate
cancer (an EORTC study): a phase III randomised trial. Lancet 2002; 360:103106.
2. D'Amico AV, Manola J, Loffredo M, et al. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized
prostate cancer: a randomized controlled trial. JAMA 2004; 292(7):821-827.
3. Pound CR, Partin AW, Eisenberger MA, et al. Natural history of progression after PSA elevation following radical prostatectomy. JAMA 1999; 281: 1591-1597.
4. Stephenson AJ, Shariat SF, Zelefsky MJ, et al. Salvage radiotherapy for recurrent prostate cancer after radical prostatectomy. JAMA 200;. 291:1325-1332.
5. Pollack A, Zagars GK, Antolak, JA, et al. Prostate biopsy status and PSA nadir level as early surrogates for treatment failure: analysis of a prostate cancer
randomized radiation dose escalation trial. International Journal of Radiation Oncology, Biology, Physics 2002; 54:677-685.
6. Papandreou CN., Daliani DD, Thall PF, et al. Results of a phase II study with doxorubicin, etoposide, and cisplatin in patients with fully characterized
small-cell carcinoma of the prostate. Journal of Clinical Oncology 2002; 20: 3072-3080.
7. Tannock IF, de Wit RB, Berry WR, et al. Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer. NEJM 2004; 351:1502-1512.
8. Petrylak DP, Tangen CM, Hussain MHA, et al. Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate
Cancer. NEJM 2004; 351:1513-1520.
9. De La Taille A, Benson MC; Bagiella E, et al. Cryoablation for clinically localized prostate cancer using an argon-based system:
complication rates and biochemical recurrence. BJU International 2000; 85:281-286.
10. Chin JL, Pautler SE, Mouraviev V, et al. Results of salvage cryoablation of the prostate after radiation: Identifying predictors of treatment
failure and complications. Journal of Urology 2001; 165:1937-1942.
11. TNM Staging, 6th Edition, Copyright ©2004 by John Wiley & Sons, Inc.
12. Abuzallouf S, Dayes I, Lukka H, Baseline staging of newly diagnosed prostate Cancer: a summary of the literature. Journal of Urology. 171(6 Pt 1):212-7, 2004 Jun.
13. Thompson IM Jr, Tangen CM, Paradelo J, et al. Adjuvant radiotherapy for pathologically advanced prostate cancer: A randomized clinical trial. JAMA 2006;296:2329 –35.
14. Bolla M, van Poppel H, Collette L, et al. European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy:
A randomized controlled trial (EORTC trial 22911). Lancet 2005;366:572– 8.
15. Wiegel T, Bottke D, Steiner U, Siegmann A, Golz R, Storkel S, et al. Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical
prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol 2009; 27: 2924-30.
Development Credits
This practice consensus algorithm is based on majority expert opinion of the GU Center Faculty at the University of Texas, MD Anderson Cancer Center. It
was developed using a multidisciplinary approach that included input from the following medical oncologists, radiation oncologist, and urologic oncologists:
Ana Aparicia, MD
Wadih Arap, MD, PhD
John Araujo, MD
‡
Seungtaek Choi, MD
‡
Paul Corn, MD, PhD
‡
John W. Davis, MD
Colin P Dinney, MD
Steven Frank, MD
Ashish Kamat, MD
Jeri Kim, MD
Deborah A Kuban, MD
‡
Andrew K. Lee, MD, MPH
Christopher J Logothetis, MD
Surena Matin, MD
Randall E Millikan, MD, PhD
Lance C Pagliaro, MD
Curtis A Pettaway, MD
Louis L Pisters, MD
David A Swanson, MD
Shi-Ming Tu, MD
John F. Ward, MD
Amado Zurita-Saavedra, MD
Core Development Team

Document 6480470

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