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Table 2 Characteristics of agent trials included in systematic review

From: Neo-adjuvant hormone therapy for non-metastatic prostate cancer: a systematic review and meta-analysis of 5,194 patients

Author

Inclusion criteria

Exclusion criteria

Dose (NHT)

Interventions

Follow-up time

Pilepich 2001 [12]

Tumor size was measured by the surface area palpable by rectal examination. Performance score (KPS) = 60 positive lymph nodes if below the common iliac level

Patients with involved common peri-aortic or iliac lymph node

2 months goserelin acetate ((3.6 mg every 4 weeks) flutamide (250 mg tid)

NHT followed by RT and continued during RT versus RT alone. Pelvis: 44 to 46 Gy, Prostate: 65 to 70 Gy, 33 fractions/6.5 weeks

Median: 6.7 years

Laverdiere 2004 [13]

Age <75 years, PSA <50 mg/ml, without bone metastases

No previous hormonal therapy or chemotherapy

3 months leuprolide (7.5 mg monthly) flutamide (250 mg tid)

NHT followed by RT versus RT alone. Pelvis: 64 Gy, 32 fractions/6.5 weeks

Median: 3.7 years

Soloway 1995 [14]

Age <75 years, PSA <50 ng/ml, normal bone scan

No previous hormonal therapy or chemotherapy

2 weeks leuprolide (7.5 mg monthly) flutamide (250 mg tid)

NHT followed by RP versus RP alone

Median: unknown

Denham 2005 [15]

No bone metastases, prostatic acid phosphatase <1.8 u/ml, PSA <50 ng/ml

Renal dysfunction, hepatic disease, other malignancies or concomitant anti-androgenic medication

3 months cyproterone acetate (300 mg daily for 12 weeks), 6 months cyproterone acetate

3 or 6 months NHT followed by RT versus RT alone. Prostate/seminal vesicles: 66 Gy, 33 fractions/6.5 to 7 weeks

Median: 5.9 years

Roach 2008 [5]

bulky (5*5 cm) tumors, with or without pelvic lymph node involvement

no follow-up data

2 months flutamide (250 mg tid), goserelin (3.6 mg every 4 weeks)

NHT followed by RT versus RT alone. Regional lymphatics: 44 to 46 Gy prostate: 65 to 70 Gy

Median: 11.9 years

Deham 2011 [6]

Histologically confirmed, informed consent

Significant intercurrent medical conditions, prior malignancies or metastases

Goserelin (3.6 mg given subcutaneously every month), flutamide (250 mg tid)

3 or 6 months NHT followed by RT versus RT alone. Prostate and seminal vesicles: 66 Gy, 33 fractions/6.5 to 7 weeks

Median: 10.6 years

Dalkin 1996 [16]

PSA >4.0 ng/ml, projected survival >10 years

No record

3 months goserelin (s.c 3.6 mg monthly)

NHT followed by RP versus RP alone.

Median: unknown

Goldenberg 1996 [17]

Histologically confirmed, prostatic acid phosphatase <1.8 u/ml, PSA <50 ng/ml

Renal dysfunction, hepatic disease, other malignancies or concomitant anti-androgenic medication

Cyproterone acetate (300 mg daily for 12 weeks)

NHT followed by RP versus RP alone

Median: unknown

Labrie 1997 [18]

Histologically confirmed, life expectancy >10 years

No record

3 months flutamide and leuprolide acetate

NHT followed by RP versus RP alone

Median: unknown

Schulman 2000 [9]

Histologically confirmed, PSA <100 ng/ml

No record

3 months goserelin (3.6 mg subcutaneously depot injection each month) flutamide (250 mg tid)

NHT followed by RP versus RP alone

Median: 4.0 years

Selli 2002 [19]

Histologically confirmed, informed consent

No record

Goserelin (3.5 mg subcutaneously depot injection each month) bicalutamide (50 mg/day)

3 or 6 months NHT followed by RP versus RP alone

Median: unknown

Soloway 2002 [20]

Age <75 years, PSA <50 ng/ml, normal bone scan

No previous hormonal therapy or chemotherapy

3 months leuprolide (7.5 mg monthly) flutamide (250 mg tid)

NHT followed by RP versus RP alone

Median: 5.0 years

Aus 2002 [21]

Previously untreated, age <75 years, life expectancy >10 years

Positive lymph nodes

3 months triptorelin (3.75 mg i.m. monthly)

NHT followed by RP versus RP alone

Median: 82 months

Klotz 2003 [10]

Histologically confirmed, prostatic acid phosphatase <1.8 u/ml, PSA <50 ng/ml

Renal dysfunction, hepatic disease, other malignancies or concomitant anti-androgenic medication

3 months cyproterone acetate (300 mg daily for 12 weeks)

NHT followed by RP versus RP alone

Median: 6.0 years

Prezioso 2004 [22]

Lifespan >5 years, WHO performance status up to 2, no evidence of metastases, informed consent

No previous hormonal therapy or chemotherapy, no previous orchidectomy or other malignancies

3 months leuprolide (3.75 mg) cyproterone acetate (300 mg daily for 3 weeks)

NHT followed by RP versus RP alone

Median: unknown

  1. NHT, neo-adjuvant hormone therapy; PSA, prostate-specific antigen; RP, radical prostatectomy; RT, radiotherapy; Gy, gray.