Stage II Prostate Cancer
Current Clinical Trials
Note: Some citations in the text of this section are followed by a level of
evidence. The PDQ editorial boards use a formal ranking system to help the
reader judge the strength of evidence linked to the reported results of a
therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence 1 for more
information.)
Stage II prostate cancer is defined by the following staging systems:
- American Joint Committee on Cancer's (AJCC) TNM classification system:
- T1a, N0, M0, G2–4.
- T1b, N0, M0, any G.
- T1c, N0, M0, any G.
- T1 (not further specified), N0, M0, any G.
- T2, N0, M0, any G.
- Jewett staging system: stage A2 or B1 or B2.
[Note: Previous versions of the AJCC staging system described a tumor’s grade as moderately differentiated, poorly differentiated, or undifferentiated, but these terms are no longer used. G2 is the equivalent of moderately differentiated, and G3–4 is the equivalent of poorly differentiated and undifferentiated.]
Treatment information for patients whose disease has the following TNM classifications:
- T1a, N0, M0, G2–4.
- T1b, N0, M0, any G.
- T1c, N0, M0, any G.
- T1 (not further specified), N0, M0, any G.
- T2, N0, M0, G1–2.
A trial has been reported in which 695 men with newly diagnosed well-differentiated or moderately well-differentiated prostate cancers of clinical stages T1b, T1c, or T2 were randomly assigned to receive radical prostatectomy versus watchful waiting.[1] In contrast to prostate cancer patients in the United States, most of the men in this study had been diagnosed clinically, rather than by screening. At a median follow-up of 6.2 years, prostate cancer-specific mortality was 4.6% in the prostatectomy arm of the study versus 8.9% in the watchful waiting arm (P = .02);[1][Level of evidence: 1iiB] however, overall mortality in the two groups was similar (P = .31).[1][Level of evidence: 1iiA] After 10 years, the difference in overall survival (OS) was approximately 73% versus 68%; absolute difference 5.0%; relative risk of death 0.74 (95% confidence interval [CI], 0.56–0.99). This benefit was restricted to men younger than 65 years at the time of surgery (P = .01 in a planned subset analysis of the effect of age on treatment efficacy).[2] A quality-of-life substudy was conducted in 326 of the men in the randomized study.[3] Men filled out questionnaires at a median of about 4 years after study entry. The principal differences in symptoms between the two groups were in sexual and urinary function. In the surgery and watchful waiting groups, 80% versus 45% of the men answering the questionnaire said they seldom or never had erections sufficient for sexual intercourse. Forty-nine percent of men in the prostatectomy arm had urinary leakage at least once a week, 43% used protective aids regularly, and 14% used diapers or urine bags compared to 21%, 10%, and 1%, respectively, in the watchful waiting arm; however, the men on the watchful waiting arm had more obstructive symptoms (e.g., severe symptoms on the American Urologic Symptom Index of 7% in the watchful waiting arm vs. 10% in the prostatectomy arm and moderate symptoms of 42% vs. 24%).[3][Level of evidence: 1iiC]
An older randomized study
comparing radical prostatectomy at diagnosis to expectant
therapy (careful observation with therapy as needed) in stage I and stage II cancers
did not show a statistically significant difference in survival;[4] however, the trial of 95
patients was not large enough to exclude a small but medically significant
difference in OS, nor did it include information to measure time to progression, cancer-specific survival, or quality of life.
Often, baseline rates of PSA changes are thought to be markers of tumor progression. Even though a tumor marker or characteristic may be consistently associated with a high risk of prostate cancer progression or death, it may be a very poor predictor and therefore of very limited utility in making therapeutic decisions. For example, baseline PSA and rate of PSA change were associated with subsequent metastasis or prostate cancer death in a cohort of 267 men with clinically localized prostate cancer who were managed by watchful waiting in the control arm of a randomized trial comparing radical prostatectomy to watchful waiting.[5,6] Nevertheless, the accuracy of classifying men into groups whose cancer remained indolent versus those whose cancer progressed was poor at all examined cut points of PSA or PSA rate of change.
Patients with locally advanced nonmetastatic disease (T2–T4, N0–N1, M0) are at risk for developing bone metastases, and bisphosphonates are being studied as a strategy to decrease this risk. However, a placebo-controlled randomized trial (MRC-PRO4) 2 of a 5-year regimen of the first generation bisphosphonate clodronate in high oral doses (2,080 mg per day) had no favorable impact on either time to symptomatic bone metastasis or survival.[7][Level of evidence: 1iA]
Standard treatment options:
- Radical prostatectomy, usually with pelvic lymphadenectomy (with or without
the nerve-sparing technique designed to preserve potency).[8-10] Radical
prostatectomy may be difficult after a transurethral resection of the prostate (TURP).
Consideration may be given to postoperative radiation therapy for patients who
are found to have capsular penetration or seminal vesicle invasion by tumor at
the time of prostatectomy or who have a detectable level of prostate-specific
antigen (PSA) more than 3 weeks after surgery.[11-16] Because duration of follow-up
in available studies is still relatively short, the value of postoperative
radiation therapy is yet to be determined; however, postoperative radiation
therapy does reduce local recurrence.[17] Careful treatment planning is
necessary to avoid morbidity.[11-16] Clinical trials are in progress.
- Careful observation without further immediate treatment in selected
patients.[4,18]
- External-beam radiation therapy (EBRT).[19-23] Prophylactic radiation therapy to
clinically or pathologically uninvolved pelvic lymph nodes does not appear to
improve OS or prostate cancer-specific survival as seen in the Radiation Therapy Oncology Group Trial (RTOG-7706) 3 trial, for example.[24][Level of
evidence: 1iiA] Although the RTOG-9413 4 trial showed an increased progression-free survival at 4 years for patients with a 15% estimated risk of lymph node involvement receiving whole-pelvic radiation therapy as compared with prostate-only radiation therapy, OS and PSA failure rates were not significantly different.[25,26][Level of evidence: 1iiDiii] Definitive radiation therapy should be delayed 4 to 6 weeks
after TURP to reduce incidence of stricture.[27]
- EBRT plus androgen-suppression therapy.[28,29] Three-dimensional–conformal radiation therapy (3D–CRT) (70 Gy) with versus without a total of 6 months of androgen-suppression therapy ([AST]: combined-luteinizing hormone–release hormone [LHRH] plus flutamide) have been compared in a randomized trial of men with clinical stage I or stage II cancer who are at elevated risk for disease progression (i.e., PSA ≥10 mg/ml or Gleason score ≥7).[30] In the trial, 206 patients were randomly assigned and followed for a median of 4.5 years. The estimated 5-year OS rate in the radiation-only arm was 78% (95% CI, 68%–88%) versus 88% (95% CI, 80%–95%) in the radiation-plus AST arm (P = .04).[30][Level of evidence: 1iiA]
Bicalutamide has not been shown to improve OS in patients with localized or locally advanced prostate cancer. The Early Prostate Cancer (EPC) program is a large, randomized, placebo-controlled, international trial that compared bicalutamide (150 mg orally per day) plus standard care (radical prostatectomy, radiation therapy, or watchful waiting, depending on local custom) with standard care alone for men with nonmetastatic localized or locally advanced prostate cancer (T1–2, N0, NX; T3–4, any N; or any T, N+).[31] Less than 2% of the 8,113 men had known node disease. At a median follow-up of 7.4 years, there was no difference in OS between the bicalutamide and placebo groups (about 76% in both arms [hazard ratio (HR) = 0.99; 95% CI, 0.91–1.09; P = .89]).[31][Level of evidence: 1iA]
- Interstitial implantation of radioisotopes (i.e., iodine I 125, palladium, and iridium)
done through a transperineal technique with either ultrasound or computed tomography (CT) guidance is
being done in carefully selected patients with T1 or T2a tumors. Short-term
results in these patients are similar to those for radical prostatectomy or
EBRT.[32-34][Level of evidence: 3iiiDiv] One
advantage is that the implant is performed as outpatient surgery. The rate of
maintenance of sexual potency with interstitial implants has been reported to
be 86% to 92%,[32,34] which compares with rates of 10% to 40% with radical
prostatectomy and 40% to 60% with EBRT; however,
urinary tract frequency, urgency, and less commonly, urinary retention are seen
in most patients but subside with time. Rectal ulceration may also be seen.
In one series, a 10% 2-year actuarial genitourinary grade 2 complication rate and
a 12% risk of rectal ulceration was seen. This risk decreased with increased
operator experience and modification of implant technique.[32] Long-term
follow-up of these patients is necessary to assess treatment efficacy and side
effects.
Retropubic freehand implantation with iodine I 125 has been associated with an
increased local failure and complication rate [35,36] and is now rarely done.
- Other clinical trials.
Treatment information for patients whose disease has the following classifications:
- AJCC's TNM classification system: T2, N0, M0, any G.
- Jewett staging system: A2 or B1 or B2.
Radical prostatectomy, EBRT, and interstitial implantation
of radioisotopes are each employed in the treatment of stage II prostate cancer
with apparently similar therapeutic effects. Radical prostatectomy and
radiation therapy yield apparently similar survival rates with as many as 10 years
of follow-up. For well-selected patients, radical prostatectomy can achieve
15-year survival comparable to an age-matched population without prostate
cancer.[18] Unfortunately, randomized comparative trials of these treatment
methods with prolonged follow-up are lacking. Patients with a small palpable
cancer (T2a, N0, M0) fare better than patients in whom the disease involves
both lobes of the gland (T2c, N0, M0). Patients proven free of node metastases
by pelvic lymphadenectomy fare better than patients in whom this staging
procedure is not performed; however, this is the result of selection of patients who
have a more favorable prognosis. Side effects of the various forms of therapy—including impotence, incontinence, and bowel injury—should be considered in determining the type of treatment to employ.
In a
retrospective pooled analysis, 828 men with clinically localized prostate
cancer were managed by initial conservative therapy with subsequent hormone
therapy given at the time of symptomatic disease progression. This study
showed that the patients with grade 1 or grade 2 tumors experienced a
disease-specific survival of 87% at 10 years and that their
OS closely approximated the expected survival among men of similar ages in the
general population.[18] The decision to treat should be made in the context of
the patient’s age, associated medical illnesses, and personal
desires.
The role of adjuvant hormonal therapy in patients with locally advanced disease
has been analyzed by the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality). Most patients have more advanced disease, but patients with bulky T2b to T2c
tumors were included in the study groups that were re-evaluating the role of adjuvant
hormonal therapy in patients with locally advanced disease. Randomized
clinical trial evidence comparing radiation therapy to radiation therapy with prolonged
androgen suppression has been published. The meta-analysis found a difference
in 5-year OS in favor of radiation therapy plus continued
androgen suppression (LHRH agonist or orchiectomy) compared to radiation therapy alone (HR = 0.631;
95% CI, 0.479–0.831).[37][Level of evidence: 1iiA]
Likewise, a meta-analysis of seven randomized controlled trials comparing early (adjuvant or neoadjuvant) to deferred hormonal treatment (LHRH agonists and/or antiandrogens) in patients with locally advanced prostate cancer, whether treated by prostatectomy, radiation therapy, or watchful waiting, showed improved overall mortality (RR=0.86; 95% CI, 0.82–0.91).[38][Level of evidence: 1iiA]
Bicalutamide has not been shown to improve OS in patients with localized or locally advanced prostate cancer. The EPC program is a large, randomized, placebo-controlled, international trial that compared bicalutamide (150 mg orally per day) plus standard care (radical prostatectomy, radiation therapy, or watchful waiting, depending on local custom) with standard care alone for men with nonmetastatic localized or locally advanced prostate cancer (T1–2, N0, NX; T3–4, any N; or any T, N+).[31] Less than 2% of the 8,113 men had known node disease. At a median follow-up of 7.4 years, there was no difference in OS between the bicalutamide and placebo groups (about 76% in both arms [HR = 0.99; 95% CI, 0.91–1.09; P = .89]).[31][Level of evidence: 1iA]
Patients with locally advanced nonmetastatic disease (T2–T4, N0–N1, M0) are at risk for developing bone metastases, and bisphosphonates are being studied as a strategy to decrease this risk. However, a placebo-controlled randomized trial (MRC-PRO4) 2 of a 5-year regimen of the first generation bisphosphonate clodronate in high oral doses (2,080 mg per day) had no favorable impact on either time to symptomatic bone metastasis or survival.[7][Level of evidence: 1iA]
Standard treatment options:
- Radical prostatectomy usually with pelvic lymphadenectomy.[8,9,39,40] If
allowed by the extent of tumor, anatomical dissection that preserves nerves
necessary for erection may avoid impotence postoperatively in some
patients.[10,39] Since about 40% to 50% of men with clinically organ-confined disease are found to have pathologic extension beyond the prostate capsule or surgical margins (i.e., pathologic stage III disease), the role of postprostatectomy adjuvant radiation therapy has been studied. In a randomized trial of 425 men with pathologic T3, N0, M0 disease, postsurgical EBRT (60 Gy–64 Gy to the pelvic fossa over 30–32 fractions) was compared to observation.[41] The primary endpoint was metastasis-free survival, an endpoint that could be affected by serial PSA monitoring and resulting metastatic work-up for PSA increase. This could have biased the primary endpoint in favor of radiation therapy, which was associated with a lower rate of PSA rise. Nevertheless, metastasis-free survival was not statistically different between the two study arms (P = .06). After a median follow-up of 10.6 years, the median survival was 14.7 years in the radiation therapy group versus 13.8 years in the observation group (P = .16).[41][Level of evidence: 1iiA] Although the survival rates were not statistically different, complication rates were substantially higher in the radiation therapy group: overall complications were 23.8% versus 11.9%, rectal complications were 3.3% versus 0%, and urethral stricture was 17.8% versus 9.5%, respectively. Postoperative
radiation therapy does reduce local recurrence.[17] The role of preoperative (neoadjuvant) hormonal therapy is not established.[42,43] Also, the morphologic changes induced by neoadjuvant
androgen ablation may complicate assessment of surgical margins and capsular
involvement.[44]
- EBRT.[19-23,45] Prophylactic radiation therapy to clinically
or pathologically uninvolved pelvic lymph nodes does not appear to improve
OS or prostate cancer-specific survival.[24][Level of evidence: 1iiA] Definitive radiation therapy should be delayed 4 to 6 weeks after
TURP to reduce incidence of stricture.[27] For patients with
bulky T2b to T2c tumors, adjuvant hormonal therapy should be considered.[37]
- EBRT plus androgen suppression therapy.[28,29]
- Careful observation without further immediate treatment (in selected
patients).[4,18]
- Interstitial implantation of radioisotopes (i.e., iodine I 125, palladium, and iridium)
done through a transperineal technique with either ultrasound or CT guidance is
being done in carefully selected patients with T1 or T2a tumors. Short-term
results in these carefully selected patients are similar to those for radical
prostatectomy or EBRT.[32-34][Level of evidence: 3iiiDiv] One advantage is that the implant is performed as outpatient
surgery. The rate of maintenance of sexual potency with interstitial implants
has been reported to be 86% to 92%,[32,46] which compares with rates of 10% to
40% with radical prostatectomy and 40% to 60% with EBRT; however, urinary tract frequency, urgency, or less commonly, urinary
retention are seen in most patients but subside with time. Rectal
ulceration may also be seen. In one series, a 10% 2-year actuarial genitourinary
grade 2 complication rate, and a 12% risk of rectal ulceration was seen. This
risk decreased with increased operator experience and modification of implant
technique.[32] Long-term follow-up of these patients is necessary to assess
treatment efficacy and side effects.
Retropubic freehand implantation with iodine I 125 has been associated with an
increased local failure and complication rate [35,36] and is now rarely done.
- EBRT designed to decrease exposure of normal
tissues using methods such as CT-based 3-D conformal treatment
planning is under clinical evaluation.[47]
- Ultrasound-guided percutaneous cryosurgery is under clinical evaluation.
Cryosurgery is a surgical technique under development that involves destruction of prostate
cancer cells by intermittent freezing of the prostate tissue with cryoprobes and is
followed by thawing.[48][Level of evidence: 3iiiC][49,50][Level of evidence: 3iiiDiv] Cryosurgery is less well
established than standard prostatectomy, and long-term outcomes are not as well established as with prostatectomy or radiation therapy.
Serious toxic effects include bladder outlet injury, urinary incontinence,
sexual impotence, and rectal injury. The technique of cryosurgery is under
development. Impotence is common. The frequency of other side effects and the probability of cancer control at 5 years' follow-up have varied among reporting centers, and series are small compared with surgery and radiation therapy.[49,50]
- Other clinical trials, including trials of neoadjuvant hormonal therapy
followed by radical prostatectomy.[51,52]
Current Clinical Trials
Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage II prostate cancer 5. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.
General information about clinical trials is also available from the NCI Web site 6.
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