zifeng-ai/TrialReviewBench huggingface dataset:
Study: Pan et al. 201910
Study design: Cohort study
Risk level: Very high risk
Inclusion criteria: Patients had clinical stage more than cT3a, or primary Gleason pattern 5, or >=5 cores with Gleason sum 8-10, or serum PSA >=50 ng ml-1, or with pelvic metastatic lymph node involvementPatient with resectable tumor could be treated with RP and ePLNDPatients had a good general performance status with ECOG score 0-1
Interventions: NHT followed by RP and ePLND versus RP and ePLND alone
Dose (NHT): Goserelin acetate: 3.6 mg every 28 days and flutamide: 250 mg tid (duration: 4 cycles to 6 cycles of total androgen blockade)
Median PSA level (ng/ml), NHT: 71.2
Median PSA level (ng/ml), no NHT: 60.3
Lymph node involvement (%), NHT: 24.7
Lymph node involvement (%), no NHT: 13.63
Number of treatment participants: 70
Number of control participants: 44
Median follow-up time: 22.8 months
Study: McClintock et al. 20199
Study design: Cohort study
Risk level: High risk
Inclusion criteria: Patients with adenocarcinoma and no metastasis to the lymph nodes or other organs at the time of PCa diagnosis (cT1-T4N0M0)NCCN risk groups (high: T3a, Gleason score 8-10 or PSA >20 ng ml-1)
Interventions: NHT followed by RP versus RP alone
Dose (NHT): NA
Median PSA level (ng/ml), NHT: NA
Median PSA level (ng/ml), no NHT: NA
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 3293
Number of control participants: 58,959
Median follow-up time: 65.28 months
Study: Ma et al. 20198
Study design: Cohort study
Risk level: High risk
Inclusion criteria: Localized high-risk PCa (clinical stage of T1 or T2 with a PSA level >20 ng ml-1 or Gleason score >7) and limited progressive PCa (clinical stage >=T3)
Interventions: NHT followed by RP versus RP alone
Dose (NHT): GnRH agonist alone (3.75/11.25 mg of leuprolide or 3.6/10.8 mg of goserelin acetate), an androgen receptor antagonist alone, or a combination of the two. (duration: <3 months, 3-6 months, or >6 months)
Median PSA level (ng/ml), NHT: 19.96
Median PSA level (ng/ml), no NHT: 17.6
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 116
Number of control participants: 73
Median follow-up time: 26 months
Study: Kim et al. 20187
Study design: Cohort study
Risk level: High risk
Inclusion criteria: Patients with one or more risk factors: stage >=T3 and/or PSA >20 ng ml-1 and/or Gleason score sum 8-10; any stage T with pelvic nodal involvement; and clinical stage T3b or T4 disease without evidence of nodal involvement or metastasis
Interventions: NHT followed by RP versus RP alone
Dose (NHT): NHT: goserelin acetate and flutamide (the median duration: 4 months)
Median PSA level (ng/ml), NHT: NA
Median PSA level (ng/ml), no NHT: NA
Lymph node involvement (%), NHT: 27.9
Lymph node involvement (%), no NHT: 7.2
Number of treatment participants: 50
Number of control participants: 50
Median follow-up time: 49.1 months
Study: Tosco et al. 201713
Study design: Cohort study
Risk level: High risk
Inclusion criteria: Patients meeting one or more of the following criteria: clinical stage T3-T4, PSA >20 ng ml-1 or biopsy Gleason score 8-10
Interventions: NHT followed by RP versus RP alone
Dose (NHT): NA (The indication, duration and type of NHT depended on institutional protocols)
Median PSA level (ng/ml), NHT: 11.0
Median PSA level (ng/ml), no NHT: 14.0
Lymph node involvement (%), NHT: 29.5
Lymph node involvement (%), no NHT: 36.2
Number of treatment participants: 241
Number of control participants: 811
Median follow-up time: 56 months
Study: Carver et al. 20066
Study design: Cohort study
Risk level: Clinical T3
Inclusion criteria: Patients with cT3 PCa
Interventions: NHT followed by RP versus RP alone
Dose (NHT): NA
Median PSA level (ng/ml), NHT: 21.8
Median PSA level (ng/ml), no NHT: 10.0
Lymph node involvement (%), NHT: 14
Lymph node involvement (%), no NHT: 21
Number of treatment participants: 64
Number of control participants: 112
Median follow-up time: 6.4 years
Study: Schulman et al. 200011
Study design: RCT
Risk level: Clinical T3
Inclusion criteria: T3N x M0 prostatic carcinoma and a PSA level of <100 ng ml-1
Interventions: NHT followed by RP versus RP alone
Dose (NHT): Goserelin acetate: 3.6 mg every month and flutamide: 250 mg tid (duration: 3 months)
Median PSA level (ng/ml), NHT: NA
Median PSA level (ng/ml), no NHT: NA
Lymph node involvement (%), NHT: 26.4
Lymph node involvement (%), no NHT: 32.6
Number of treatment participants: 87
Number of control participants: 95
Median follow-up time: 4 years
Study: Selli et al. 200212
Study design: RCT
Risk level: Clinical T3
Inclusion criteria: C1 (cancer with extracapsular extension; pT3a); C2 (seminal vesicle invasion; pT3b; TNM, 1997 revision)
Interventions: NHT followed by RP versus RP alone
Dose (NHT): Zoladex depot: 3.5 mg every 28 days and Casodex: 50 mg per day (duration: for 12 weeks or 24 weeks)
Median PSA level (ng/ml), NHT: 10
Median PSA level (ng/ml), no NHT: 10.2
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 66
Number of control participants: 29
Median follow-up time: NA
Study: Ohashi et al. 201420
Study design: Cohort study
Risk level: High risk
Inclusion criteria: High risk localized PCa: PSA level higher than 20 ng ml-1, and/or Gleason score >=8, and/or Stage T3Prostate volumes >40 cc usually underwent ADT
Interventions: NHT followed by RT (I-125 brachytherapy plus EBRT) versus RT alone
Dose (NHT): GnRH agonist alone or in combination with an anti-androgen (median duration: 4 months)
Median PSA level (ng/ml), NHT: 11.95
Median PSA level (ng/ml), no NHT: 11.95
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 101
Number of control participants: 105
Median follow-up time: 60 months
Study: Nanda et al. 201419
Study design: Cohort study
Risk level: High risk
Inclusion criteria: High risk localized PCa: PSA level higher than 20 ng ml-1, and/or Gleason score>=8, and/or Stage T3Men in the study had no or at least a single risk factor and no documented history of coronary artery disease at the time of enrollment
Interventions: NHT followed by RT (brachytherapy with or without EBRT) versus RT alone
Dose (NHT): NA (median duration: 4 months)
Median PSA level (ng/ml), NHT: 14.9
Median PSA level (ng/ml), no NHT: 20.0
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 1007
Number of control participants: 353
Median follow-up time: 4.6 years
Study: Denham et al. 201116
Study design: RCT
Risk level: High risk
Inclusion criteria: Patients with one or more of the following are regarded as high risk: stage T2c, T3, or T4 disease; a Gleason score of >7; or initial PSA concentration of more than 20g l-1; without evidence of lymph-node involvement and metastasesNo upper limit on PSA level was set
Interventions: NHT followed by RT and continued during RT versus RT alone. Prostate/seminal vesicles 66 Gy, 33 fractions/6.5-7.0 weeks
Dose (NHT): Goserelin acetate: 3.6 mg every month and flutamide: 250 mg tid (duration: 6 months)
Median PSA level (ng/ml), NHT: 14.6
Median PSA level (ng/ml), no NHT: 16.4
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 224
Number of control participants: 222
Median follow-up time: 10.6 years
Study: Denham et al. 200515
Study design: RCT
Risk level: High risk
Inclusion criteria: Patients with one or more of the following are regarded as high risk: stage T2c, T3, or T4 disease; a Gleason score of >7; or initial PSA concentration of more than 20 g l-1; without evidence of lymph-node involvement and metastasesNo upper limit on PSA level was set
Interventions: NHT followed by RT and continued during RT versus RT alone. Prostate/seminal vesicles 66 Gy, 33 fractions/6.5-7.0 weeks
Dose (NHT): Goserelin acetate: 3.6 mg every month and flutamide: 250 mg tid (duration: 6 months)
Median PSA level (ng/ml), NHT: 14.6
Median PSA level (ng/ml), no NHT: 16.4
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 224
Number of control participants: 222
Median follow-up time: 5.9 years
Study: Milecki et al. 200918
Study design: Cohort study
Risk level: High risk
Inclusion criteria: Patients with one or more of the following are regarded as high risk: Gleason score >7 or initial PSA level >20 ng ml-1 or T3All patients represented good general performance status defined as 0 or 1 according to ECOG classificationAll patients had a histological diagnosis of adenocarcinoma
Interventions: NHT followed by WPRT and continued during WPRT versus RT alone. Prostate/seminal vesicles 70.2 Gy/1 weeks
Dose (NHT): Goserelin acetate: 10.8 mg every 3 months and flutamide: 250 mg tid for 4 weeks (the median duration: 4.4 months)
Median PSA level (ng/ml), NHT: 37.3
Median PSA level (ng/ml), no NHT: 38.1
Lymph node involvement (%), NHT: 73
Lymph node involvement (%), no NHT: 59
Number of treatment participants: 70
Number of control participants: 92
Median follow-up time: 55 months
Study: Paterson et al. 201621
Study design: Cohort study
Risk level: High risk
Inclusion criteria: Patients >70 years of age who were diagnosed with histologically confirmed, localized, or locally advanced adenocarcinoma of the prostatePatients suitable and those opting for primary RT, neoadjuvant/adjuvant hormonal therapy for 24 months, and radiotherapyPatients with one or more of high-risk factors: Gleason score 8-10 or initial PSA level >=20 ng ml-1 or stage >=T2c
Interventions: NHT followed by RT versus RT alone
Dose (NHT): NA
Median PSA level (ng/ml), NHT: 12.8
Median PSA level (ng/ml), no NHT: 13.0
Lymph node involvement (%), NHT: NA
Lymph node involvement (%), no NHT: NA
Number of treatment participants: 167
Number of control participants: 117
Median follow-up time: 40.9 months
Study: Eom et al. 201417
Study design: Cohort study
Risk level: High risk
Inclusion criteria: High-risk group: Gleason score >=8 or PSA >20 ng ml-1 or stage >=T3aLocalized patients (cT1-T4, N0, and M0) with >3 years of follow-up
Interventions: NHT followed by RT and continued during RT versus RT alone. (1.8 Gy per fraction in 7-10 weeks)
Dose (NHT): GnRH agonist combined with anti-androgen agent (n=84). Anti-androgen agent alone (18). Bilateral orchiectomy (n=1; median duration: 3.3 months)
Median PSA level (ng/ml), NHT: NA
Median PSA level (ng/ml), no NHT: NA
Lymph node involvement (%), NHT: -
Lymph node involvement (%), no NHT: -
Number of treatment participants: 69
Number of control participants: 27
Median follow-up time: 91.2 months
Study: Roach et al. 200814
Study design: RCT
Risk level: B2+C
Inclusion criteria: Patients with bulky (defined as 5 cm x 5 cm) tumors (T2-T4) according to the 1988 American Joint Committee on Cancer TNM staging systemPatients were eligible with or without pelvic lymph node involvement and were randomly assigned to receive combined ADT
Interventions: NHT followed by RT and continued during RT versus RT alone (regional lymphatics 44 Gy-46 Gy/prostate 65 Gy-70 Gy, 1.8 Gy-2 Gy 1 day given 4 times-5 times a week)
Dose (NHT): Goserelin acetate: 3.6 mg every month and flutamide: 250 mg tid for 2 months before RT (duration: 112 days)
Median PSA level (ng/ml), NHT: 22.6
Median PSA level (ng/ml), no NHT: 33.8
Lymph node involvement (%), NHT: NA
Lymph node involvement (%), no NHT: NA
Number of treatment participants: 224
Number of control participants: 232
Median follow-up time: 13.2 years