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Table 3 Study characteristics

From: Early versus deferred androgen suppression therapy for patients with lymph node-positive prostate cancer after local therapy with curative intent: a systematic review

 

RTOG-85-31[9, 10]

Granfors et al.[11, 12]

EST-3886[13–15]

EPC program[16, 17]

Design

prospective RCT (1987–1992)

prospective RCT (1986–1991)

prospective RCT (1988–1993)

prospective RCT (1995–1998)

Included participants

173 patients with lymph node-positive prostate cancer and no distant metastases at study entry; no prior AST

39 patients with lymph node-positive prostate cancer and no distant metastases at study entry; no prior AST

98 patients with lymph node-positive prostate cancer and no distant metastases at study entry; no prior AST

88 patients with lymph node-positive prostate cancer and no distant metastases at study entry; no prior AST

Local therapy

radiotherapy (65–70 Gy) with/without radical prostatectomy

radiotherapy (mean 64.9-65.2 Gy)

radical prostatectomy

radical prostatectomy (74 patients) or radiotherapy (14 patients; mean 65 Gy) (c)

Lymph node assessment

mandatory (done by lymphangiogram, computed tomography, lymphadenectomy)

mandatory (done by lymphadenectomy)

mandatory (done by lymphadenectomy)

mandatory (c) (done by lymphadenectomy, computed tomography) (d)

Intervention (early AST)

LHRH analogues (goserelin, initiated during last week of radiotherapy; 98 patients)

orchiectomy (initiated at time of local therapy; 20 patients)

LHRH analogues (goserelin)/orchiectomy (initiated at time of local therapy; 47 patients)

anti-androgen (bicalutamide 150 mg daily) (initiated at time of local therapy, 42 patients)

Control (deferred AST)

LHRH analogues (initiated at clinical progression; 75 patients) (a)

LHRH analogues/orchiectomy (initiated at clinical progression; 19 patients) (a)

LHRH analogues/orchiectomy (initiated at clinical progression; 51 patients) (a, b)

AST at investigators discretion (initiated at clinical progression; 46 patients) (a)

Follow-up

median 6.5 years for all patients, 9.5 year for survivors

median 9.3 years for all patients (14–19 years), 16.5 years for survivors

median 11.9 years

median 3 years

Definition of clinical progression

local progression: reappearance of palpable tumor after initial clearance, progression of palpable tumor (at any time), or biopsy-proven presence of carcinoma of the prostate 2 years or more after study entry. regional progression: clinical or radiographic evidence of tumor in the pelvis with or without palpable tumor in the prostate by digital examination (a)

occurrence of clinical evident local tumor growth or bone or other distant metastases (a)

evidence of recorded clinical progression or death from any cause (a)

occurrence of objective progression (confirmed by bone scan, magnetic resonance imaging, ultrasonography, or computed tomography scan) or death without progression (a)

  1. AST, androgen suppression therapy; RCT, randomized controlled trial; Gy, Gray; LHRH, luteinising hormone-releasing hormone.
  2. (a). Testing of prostate-specific antigen (PSA) was not used for definition of clinical progression.
  3. (b). Use of AST was delayed if only local recurrence was suspected and physicians were advised to treat with local treatment (i.e. radiotherapy) first [13, 15].
  4. (c). Besides radical prostatectomy and radiotherapy, watchful waiting was also investigated as standard treatment. Only patients that underwent local therapy (radical prostatectomy, radiotherapy) were included in this review.
  5. (d). Authors “assumed that most radical prostatectomy patients were assessed at surgery, suggesting that most patients with node-positive disease had a histologically confirmed nodal status” [16].
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BMC Cancer

ISSN: 1471-2407

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