SPCG Protocols (Projects)

(SPCG-1) (SPCG-2) (SPCG-3) (SPCG-4) (SPCG-5) (SPCG-6) (SPCG-7/SFUO-3)
(SPCG-8) (SPCG-9) (Posapro/SPCG) (SPCG-10) (SPCG-11) (SPCG-12) (SPCG-13)

SPCG-1
Title: Comparison of Estramustine Phosphate to Stilbestrol in the treatment of G3 M+ Prostatic
Cancer.
Patients: T1-4,Nx,M1,G2-3 or G3.
Treatment: Estramustine 560 mg versus Diethylstilbestrol 3 mg daily.
Inclusion period: 1984 – 1989. Number of patients: 197.
Principal investigator: Per Olov Hedlund
Publication: Hedlund PO, Jacobsen H, Vaage S, Hahne B, Sandin T, Kontturi M, Nordle Ö,
Esposti P and the SPCG-1-Study Group. Treatment of High-grade, High-stage Prostate
Cancer with Estramustine Phosphate or Diethylstilbestrol. Scand J Urol Nephrol
1996;31:167-172.

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SPCG-2
Title: Orchiectomy plus placebo versus orchiectomy plus cyproteronacetat.
Patients: T0-4,Nx,M1,G1-2
Treatment: Orchiectomy plus cyproterone acetate versus orchiectomy plus placebo
Inclusion period: Sep 1984 - March 1989 Number of patients: 294.
Principal investigator: Kjell Tveter
Publications:

Papers

1. Jørgensen T, Tveter KJ, Jørgensen LH, SPCG-2 group. Total androgen suppression:
   Experience from the Scandinavian Prostate Cancer Group Study No. 2. Eur Urol
   1993;24:466-470.
2. Jørgensen T, Müller C, Kaalhus O, Danielsen HE, Tveter KJ. Extent of disease based on
   initial bone scan: Important prognostic predictor for patients with metastatic prostatic
   cancer. Experience from the Scandinavian Prostatic Cancer Group Study no 2 (SPCG-2).
   Eur Urol 1995; 28: 40-46.
3. Jørgensen T, Yogesan K, Skjørten F, Berner A, Tveter KJ, Danielsen HE.
   Histopathological grading and DNA ploidy as prognostic markers in metastatic prostatic
   cancer. Br J Cancer 1995;71:1055-1060.
4. Jørgensen T, Berner A, Kaalhus O, Tveter KJ Danielsen HE, Bryne M. Up-Regulation of
   the Oligosaccharide Sialyl Lewis-x: A New Prognostic Parameter in Metastatic Prostate
   Cancer. Cancer Research 1995;55:1817-1819.
5. Jørgensen T, Kanagasingam Y, Kaalhus O, Tveter KJ, Bryne M, Skjørten F, Berner A,
   Danielsen HE. Prognostic factors in patients with metastatic (stage D2) prostate cancer:
   Experience from the Scandinavian Prostatic Cancer Group Study-2. J Urol 1997;158:164-
   170.

Thesis

T. Jørgensen. Prognostic factors in metastatic prostate cancer. Experience based on the
Scandinavian Prostatic Cancer Group Study no 2. Norwegian Cancer Society, Oslo 1999.

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SPCG-3
Patients: T3,N0,M0
Treatment: Radical prostatectomy plus/minus chemotherapy.
Inclusion period: Never started – deleted by Socialstyrelsen, Sweden. Number of patients: 0
Principal investigators: Lars Collsten and Per Olov Hedlund.

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SPCG-4 SPCG-4
Title: Expectation or radical prostatectomy on early prostate cancer.
Patients: T0-2,Nx,M0,Gr1-2, age £ 75 years and expected survival ³ 10 years
Treatment: Radical prostatectomy vs. expectants.
Inclusion period: Sep. 1989 – May 1999. Number of patients: 693 patients, 14 Centers
Principal investigator: Jan-Erik Johansson.
Publications:

Papers

1. Holmberg L, Bill-Axelson A, Helgesen F, Salo JO, Folmerz P, Häggman M, Andersson SO,
   Spångberg A, Busch C, Nordling S, Palmgren J, Adami H-O, Johansson J-E, Norlén BJ
   for the Scandinavian Prostatic Cancer Group Study Number 4. A randomized trial
   comparing radical prostatectomy with watchful waiting in early prostate cancer. N Eng J
   Med 2002;347:781-789.
2. Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson J-E, Norlén BJ, Holmberg L
   for the Scandinavian Prostatic Cancer Group Study Number 4. Quality of life after Radical
   Prostatectomy or Watchful Waiting. N Eng J Med 2002;347:790-796.
3. Bill-Axelson A, Holmberg L, Ruutu M, Häggman M, Andersson S-O, Bratell S, Spångberg
   A, Busch C, Nordling S, Garmo H, Palmgren J, Adami H-O, Norlén BJ, Johansson, J-E for
   the Scandinavian Prostate Cancer Study Group Study No. 4. Radical Prostatectomy versus
   Watchful Waiting in Early Prostate Cancer. N Eng J Med 2005;352:1977-1984.
4. Anna Bill-Axelsson. Localized Prostate Cancer. Results from a Randomized Clinical Trial.
   Thesis Uppsala University. Acta Universitatis Upsaliensis 2005. ISBN 91-554-6206-5.
5. Holmberg L, bill-Axelson A, Garmo H, Palmgren J, Norlén HB, Adami H-O, Johansson JE.
   Scandinavian Prostate Cancer Group study No 4. Prognostic markers under watchful
   waiting and radical prostatectomy. Hematology/Oncology Clinics of North America
   2006;20:845-856.
6. Fall K, Garmo H, Andrén O, Bill-Axelson, Adolfsson J, Adami H-O,Johansson J-E,
   Holmberg L. Prostate-specifik antigen levels as a predictor of lethal prostate cancer. J Natl
   Cancer Inst 2007;99:626-532.

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SPCG-5 SPCG-5
Title: High-dose Polyestradiol Phosphate versus Total Androgen Blockade.
Patients: T0-4,Nx,M1,Gr1-3
Treatment: Estradurin 240 mg / 4. week vs. decapeptyl/orchiectomy plus Eulexin 250 mg x 3 daily.
Inclusion period: Dec. 1992 – July 1997. Number of patients: 915 pat., 65 Centres.
Principal investigator: Per Olov Hedlund. Database at Parmacia, Lund and latest in Umeå.
Publications:

Papers

1. Hedlund PO, Henriksson P, and the Scandinavian Prostatic Cancer Group (SPCG)-5 Trial
   Study. Parenteral Estrogen versus Total Androgen Ablation in the Treatment of Advanced Prostate Carcinoma: Effects on Overall Survival and Cardiovascular Mortality. Urology
   2000;55:328-333.
2. Spetz A-C, Hammar M, Lindberg B, Spångberg A, Varenhorst E and the Scandinavian
   Prostatic Cancer Group-5 Trial Study. Prospective evaluation of hot flashes during
   treatment with parenteral estrogen or complete androgen ablation for metastatic carcinoma
   of the prostate. J Urol 2001;166:517-520.
3. Hedlund PO, Ala-Opas M, Brekkan E, Damber JE, Damber L, Hagerman I, Haukaas S,
   Henriksson P, Iversen P, Pousette Å, Rasmussen F, Salo J, Vaage S, Varenhorst E and the
   SPCG-5 Study Group. Parenteral Estrogen versus Combined Androgen Deprivation in the
   Treatment of Metastatic Prostatic Cancer. Scandinavian Prostatic Cancer Group (SPCG)
   Study No. 5. Scand J Urol Nephrol 2002;36:405-413.
4. Jønler M, Nielsen OS, Groenvold M, Hedlund PO, Damber L, Hedelin H, Waldén M, & the
   Sandinavian Prostate Cancer Group Study 5 Study Group. Quality of life in patients with
   skeletal metastases of prostate cancer. Status prior to start of endokrine therapy. Results
   from the Scandinavian prostate Cancer Group study 5. Scand J Urol Nephrol 2005;39:42-
   48.
5. Brasso K, Christensen IJ, Johansen JS, Teisner B, Garnero P, Price PA, Iversen P. Prognostic
   value of serum PINP, bone alkaline phosphatase, CTX-I, and YKL-40 in patients with
   metastatic prostate carcinoma. The Prostate 2006; 66(5): 503-513.
6. Johansen JS, Brasso K, Iversen P, Teisner B, Garnero P, Price PA, Christensen IJ. Changes of
   Biochemical Markers of Bone Turnover and YKL-40 Following Hormonal Treatment for
   Metastatic Prostate Cancer Are Related to Survival. Clin Cancer Res 2007;13:3244-3249.

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SPCG-6
Title: A randomized, double-blind, parallel-group trial comparing Casodex 150 mg once daily with
placebo in patients with non-metastatic prostate cancer.
Patients: T1b-4,Nx,M0,Gr1-3. 18-75 years.
Treatment: Casodex 150 mg daily vs. placebo.
Inclusion period: Nov. 1995 – May 1998. Number of patients: 1218
Principal investigator: Peter Iversen.
Publications:

Papers

1. See W, McLeod D, Iversen P, Wirth M. The bicalutamide early prostate cancer program
   demography. Urologic Oncology 2001;6:43-47.
2. See WA, Wirth MP, McLeod DG, Iversen P, Klimberg I, Gleason D, Chodak G, Montie J,
   Tyrrell C, Wallace DMA, Delaere KPJ, Vaage S, Tammela TLJ, Lukkarinen O, Persson BE,
   Carroll K, Kolvenbag GJCM on behalf of the Casodex Early Prostate Cancer Trialist
   Group. Bicalutamide as immediate therapy either alone or as adjuvant to standard care of
   patients with localized or locally advanced prostate cancer: First analysis of the early
   prostate cancer program. J Urol 2002;168:429-435.
3. Iversen P, Tammela TLJ, Vaage S, Lukkarinen O, Lodding P, Bull-Njaa T, Viitanen J,
   Hoisaeter P, Lundmo P, Rasmussen F, Johansson J-E, Persson B-E, Carroll K,
   Scandinavian Prostatic Cancer Group (SPCG). A randomised comparison of bicalutamide
   (“Casodex”) 150 mg versus placebo as immediate therapy either alone or as adjuvant tostandard care for early non-methastatic prostate cancer. First report from the Scandinavian
   Prostatic Cancer Group Study no. 6. European Urology 2002;42:204-211.
4. Wirth M, Iversen P, McLeod D, See W. Immediate therapy in early prostate cancer: Results
   from the bicalutamide (Casodex) EPC Programme. Eur Urol Suppl 2002; 1(7):20-25.
5. Iversen P, Newling D, Kirby R, Eadrley I. Sexual function: quality of life issues in patients
   with locally advanced non-metastatic prostate cancer. Eur Urol Suppl 2002;1(7):26-32.
6. See W, Iversen P, Wirth M, McLeod D, Garside L, Morris T. Immediate treatment with
   Bicalutamide 150 mg as adjuvant therapy significantly reduces the risk of PSA progression
   in early prostate cancer. Eur Urol 2003;44:512-518.
7. Iversen P. Bicalutamide monotherapy for early stage prostate cancer: an update. J Urol
   Suppl. 2003;170 (6) S48-S54.
8. Payne H, Tyrrell CJ, See WA, McLeod DG, Wirth MP, Iversen P, Garside L. Bicalutamide
   150 mg as adjuvant to radiotherapy significantly increases progression-free survival in early
   prostate cancer. Int J Radiat Oncol Biol Phys 2003; 57 (2 suppl): 173-174.
9. Iversen P, Wirth MP, See WA, McLeod DG, Klimberg I, Gleason D, Chodak G, Montie J,
   Tyrrell C, Wallace DMA, Delare KPJ, Lundmo P,Tammela TLJ, Johansson J-E, Morris T,
   Carrol K, ON Behalf of the Casodex Early Prostate Cancer Trialist Group. Is the efficacy of
   hormonal therapy affected by lymph node status? Data from the bicalutamide (Casodex)
   Early Prostate Cancer Program. Urology 2004;63:928-933.
10. Wirth M, See WA, McLeod D, Iversen P, Morris T, Carrol C, The Casodex Early Prostate
    Cancer Trialist Group. Bicalutamide 150 mg in addition to standard care in patients with
    localized or locally advanced prostate cancer: results from the second analysis of the early
    prostate cancer program at median followup of 5.4 years. J Urol 2004;172(Part 1):1865-
    1870.
11. Iversen P, Johansson Jan-Erik, Lodding P, Lukkarinen O, Lundmo P, Klarskov P, Tammela
    TLJ, Tasdemir I, Morris T, Carrol K, The Scandinavian Prostatic Cancer Group.
    Bicalutamide (150 mg) versus placebo as immediate therapy alone or as adjuvant to therapy
    with curative intent for early nonmetastatic prostate cancer: 5.3-year median followup from
    The Scandinavian Prostate Cancer Group Study number 6. J Urol 2004;172(Part 1):1871-
    1876.
12. Stranne J, Hugosson J, Iversen P, Morris T, Lodding P. Inguinal hernia in stage M0
    prostate cancer: a comparison of incidence in men treated with and without radical
    retropubic prostatectomy - an analysis of 1105 patients. Urology 2005; 65: 847-851.
13. Tyrrell CJ, Payne H, See WA, McLeod DG, Wirth MP, Iversen P, Armstrong J, Morris C.
    Bicalutamide ('Casodex') 150 mg as adjuvant to radiotherapy in patients with localised or
    locally advanced prostate cancer: results from the randomised Early Prostate Cancer
    Programme. Radiother Oncol. 2005 Jul;76(1):4-10.
14. Mcleod DG, Iversen P, See WA, Morris T, Armstrong J, Wirth MP on behalf of the
    Casodex Early Prostate Cancer Trialists' Group. Bicalutamide 150 mg plus standard care vs
    standard alone for early prostate cancer. BJU Internat 2006;97:247-254.
15. Iversen P, Johansson J-E, Lodding P, Kylmälä T, Lundmo P, Klarskov P, Tammela T,
    Tasdemir I, Morris T, Amstrong J. Bicalutamide 150 mg in addition to standard care for
    patients with early non-metastatic prostate cancer: updated results from the Scandinavian
    Prostate Cancer Group Study-6 after a median follow-up period of 7.1-years. Scand J Urol
    Nephrol 2006;40:441-452.
16. Brasso K, Christensen IJ, Johansen JS, Teisner B, Garnero P, Price PA, Iversen P.
    Prognostic value of serum PINP, bone alkaline phosphatase, CTX-I, and YKL-40 in
    patients with metastatic prostate carcinoma. The Prostate 2006; 66(5): 503-513.
17. Warren KS, Chodak GW, See WA, Iversen P, McLeod D, Wirth M, Morris C, Armstrong J.
    Are bone scans necessary in men with low prostate specific antigen levels following localized
    therapy? Journal of Urology 2006; 176(1): 70-73.
18. Iversen P. The third analysis of the bicalutamide early prostate cancer programme. British
    Journal of Urology International 2006; 97(3): 438-439.

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SPCG-7
Title: Randomized trial of locally advanced prostate cancer. Antiandrogen treatment with or without
radiotherapy.
Patients: T3,Gr1-3, (T1b,T1c,T2, Gr2-3 optional), N0 ,M0, PSA
70, Age
75 years.
Treatment: Procren depot + Eulexin 250 mg x 3 daily for 3 months. Thereafter Eulexin 250 mg x 3
daily plus/minus radiotherapy (minimum 70 Gy to the prostate and 50 Gy to the seminal
vesicles).
Inclusion period: Feb. 1996 - 311202 Number of patients: 880.
Principal investigator: Anders Widmark. Data base in Umeå and monitor function in Lund.

Publication:

1. Widmark A, Fosså SD, Lundmo P, Damber J-E, Vaage S, Damber L, Wiklund F, Klepp O.
   Does prophylactic breast irradiation prevent antiandrogen induced gynecomastia?
   Evaluation of 253 patients in the randomized Scandinavian trial SPCG-7/SFUO-3. Urology
   2003;61:145-151.

SPCG-7 Biopsy study
Title: Post-treatment Prostatic Biopsies after Antiandrogen treatment with or without Radiotherapy.
Aims: 1. To compare the incidence of residual local tumour following hormonal treatment with the
analogue incidence rate after the combination of hormonal treatment and radiotherapy. 2. To
study the prognostic implication of post-treatment residual tumour in patients included in
SPCG-7. 3. To obtain storage of post-treatment biopsies for the possibility of further
characterisation of residing tumour cells by means of immunohistochemical staining methods
for potential prognostic markers."
Patients: Three years follow-up on SPCG-7/SFUO-3 implemented in centres in Sweden and
Norway.
Inclusion period: Spring 2002 - Number of patients: Aim 200 patients
Principal investigator: Anders Widmark and Anders Angelsen

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SPCG-8
Title: Institution of second-line Estracyt therapy at an increase in PSA values for metastatic prostate
cancer.
Patients: Tany,Nany,M1, PSP 0-1 (WHO 0-1 and Pain 0), Testosterone £ 1.0 nmol/ml, Life
expectancy ³ 6 months with respond to first line hormone manipulation (PSA < 10 ng/ml or
decrease by ³ 50%) and following this increase in PSA (PSA > 10 or ³ 50%).
Treatment: Estracyt 10 mg/kg + acetylsalicylic acid 150 mg per day vs. placebo + acetylsalicylic
acid 150 mg per day.
Inclusion period: 1996 - 150398. Number of patients: 48 pat. (aim 230)
Principal investigator: Per-Anders Abrahamsson (Denmark Knud Pedersen)
Publication: Report to Legal authorities 2001.
Principal investigator: Per-Anders Abrahamsson.
Sponsor: Pharmacia
Publication: Report to Legal authorities 2001.

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SPCG-9
Title: An open pilot study evaluating intermittent androgen suppression in patients with advanced
prostate cancer.
Patients: T3-4 ,Nx,M0 / T1-4,Nx,M1. PSA  20.
Treatment: GnRH (plus flare protection) for 9 months. Intermittent treatment, if PSA-response
4.
Treatment pauses until PSA > 20.
Inclusion period: Dec. 1998 – March 2000. Number of patients: 142 pat. Data cut off: may 2002
Principal investigator: Per-Anders Abrahamsson. Knud V. Pedersen
Sponsor: AstraZeneca, Ferring and Schering-Plough
Publication:

1. Pedersen KV on behalf of the Scandinavian Prostatic Cancer Group trial No. IX. SPCG IX – an
   open multicenter trial on intermittent endocrine therapy in patients with locally advanced or
   metastatic prostate cancer. Podium presentation 26th annual congress of the Scandinavian
   Association of Urology. Abstract 2 Scand J Urol Nephrol 2007;41 Suppl 217:8.

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Posaproca/SPCG
Title: Antiandrogen followed by TAB on biochemical progression versus TAB
Patients: Tx,Nx,Gx,M1
Treatment: Leuprolide + flutamide 250 mg x 3 (A) versus flutamide 250 mg x 3 (B) follow on
progression by withdrawal of flutamide (A) and leuprolide (B).
Inclusion period: 1992 - 311203 Number of patients: 468
Principal investigator: Jonas Hugosson
Sponsor: OrionPharma and Schering Plough
Publication:

1. Bergdahl, S. Step-up therapy with Flutamide followed by combined endocrine
   treatment in men with metastatic prostate cancer. Results from SPCG/Posaproca. Abstract
   book Scandinavian Association of Urology Gothenburg June 2005.

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SPCG-10
Title: Randomised trial comparing radical prostatectomy versus radiotherapy plus protocol on
follow-up of non-randomised patients with localised prostate cancer
Patients: T1-T2, N0-Nx, M0-Mx, PSA < 20, life expectancy > 10-15 years
Treatment:
Inclusion period: Trial abandoned Number of patients: 0
Principal investigator:
Sponsor: 0
Publication: 0

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SPCG-11
Title: Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk
prostate cancer patients. A randomized, open-label, multicenter study of the European
Association of Urology (EAU) in cooperation with the Scandinavian Prostate Cancer Group
(SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO).
Patients: Tx,Nx,M0,ECOG=0, life expectancy > 6 months, ± intended curative treatment, hormone
naïve and starting castration therapy, and at least one of the following: Gleason = 8 -10, pN+ or
PSA >= 20 on diagnosis.
Treatment: vitamin D 400 IU and Calcium 500 mg p.o. per day ± Zoledronic acid 4 mg i. v. every 3
months for 48 months.
Primary study objective: Rate of bone metastases assessed by bone scan and x-ray after 48 months.
Inclusion period: 2004 -
Number of patients: SPCG 250 pat., total nr. 1300 pat.
Principal investigator: EAU Manfred Wirth. SPCG Teuvo Tammela (Denmark Jesper Rye
Andersen, Norway Anders Angelsen, Sweden Jan-Erik Damber).
Data management: EAU office in Arnheim. Monitoring by national arrangements.

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SPCG-12
Title: An open randomised phase III trial of six cycles of docetaxel versus surveillance after radical
prostatectomy in prostate cancer patients with high grade pT3 or margin positive pT2.
Patients: pT3 or pT2 with positive magins, Nx or N0 at PSA10,M0,ECOG=0/1. 18-70 years.
Treatment: Docetaxel 75 mg/m² 6 times with 3 weeks in between versus surveillance, and with start
within 12 weeks after radical prostatectomy.
Primary study objective: PSA progression (PSA 0.5), follow-up 5 years.
Secondary endpoints: PSA doubling time, Quality of life, Metastasis-free survival, overall
survival
Inclusion period: 2005 - 2008. Follow-up until 2013
Number of patients: SPCG 396.
National investigators Sweden: Göran Ahlgren (Coordinating) and Per Flodgren. Denmark: Michael
Borre and Lisa Sengelev. Finland: Teuvo Tammela and Pirkko-Liisa Kellokumpu-Lehtinen.
Norway: Anders Angelsen and Jon R Iversen
Data management: South Sweden Oncology Centre.
Monitoring: Local nurses

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SPCG-13
Title: A Randomized phase III trial of six cycles of docetaxel versus surveillance plus hormonal
treatment after radical radiotherapy in patients with intermediate or high-risk prostate cancer
(SPCG-13 AdRad).
EudraCT nr 2006-001657-94
Patients: T2, Gleason 7(4+3), PSA>10 ng/ml or T2, Gleason 8-10, any PSA or T3 prostate cancer
diagnosed within 9 months in men>18 and
75 years
Treatment: neoadjuvant LHRH analog 3 months before, 3 months during and 3 months after
radiotherapy of at least 74 Gy or brachytherapy plus/minus 6 cycles of docetaxel 75 mg/m²
(control arm no docetaxel until PSA progression)
Primary study objective: PSA progression rate (ASTRO guidelines)
Secondary endpoints: PSA doubling time after progression, quality of life, safety, metastases free
survival, overall survival.
Inclusion period: 2006 – 2009. Follow-up until end 2014. Report 2015
Number of patients: 924 in 3 years, duration 5 years, start 2006
Statistical power 90 % for level of significance 5 % with 840 evaluable subjects
Coordinating investigator Pirkko-Liisa Kellokumpu-Lehtinen Finland
Data management: Tampere University Hospital
Monitoring: National basis

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