NCT01272050已完成3 期
Dose Intensified Salvage Radiotherapy in Biochemically Relapsed Prostate Cancer Without Macroscopic Disease. A Randomized Phase III Trial.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 28
- 主要终点
- Freedom from biochemical progression
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with relapsed prostate cancer.
PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy and comparing two radiation therapy regimens in treating patients with relapsed prostate cancer after surgery.
详细描述
OBJECTIVES:
- To determine the tumor control in patients with biochemically relapsed prostate cancer without macroscopic disease treated with dose-intensive salvage radiotherapy.
- To determine the toxicity in these patients.
- To determine the quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), pathological tumor classification (pT3b vs others), lymphadenectomy performed (yes [pN0] vs no [cN0]), persistent PSA after prostatectomy (detectable [≥ 0.1 ng/mL] vs undetectable [< 0.1 ng/mL]), PSA at randomization (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center, and radiotherapy technique (3-dimensional conformal radiation therapy [3D-CRT] vs intensity-modulated radiation therapy [IMRT]/rotational techniques). Patient are randomized to 1 of 2 treatment arms.
- Arm A: Beginning at least 12 weeks after surgery, patients undergo radiotherapy* once a day, 5 days a week, for 6.4 weeks for a total dose of 64 Gy (in 32 fractions of 2 Gy over 6.4 weeks).
- Arm B: Patients undergo radiotherapy* once a day, 5 days a week, for 7 weeks for a total dose of 70 Gy (in 35 fractions of 2 Gy over 7 weeks).
NOTE: *3-dimensional conformal radiation therapy, rotational techniques such as Tomotherapy®, Rapidarc®, or intensity-modulated arc technique and volumetric-modulated arc therapy are all eligible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of adenocarcinoma of the prostate
- •Lymph node negative disease
- •Stage pT2a-3b; R0-1; pN0 or cN0
- •Undergone a radical prostatectomy ≥ 12 weeks prior to randomization
- •PSA progression after prostatectomy defined as two consecutive rises with the second rising value > 0.1 ng/mL OR three consecutive rises (the first value must be measured 4 weeks after radical prostatectomy)
- •PSA ≤ 2 ng/mL at randomization
- •No persistent PSA > 0.4 ng/mL, 4-20 weeks after radical prostatectomy
- •No palpable prostatic fossa mass suggestive of recurrence, unless an ultrasound-guided biopsy is non-malignant
- •No pre-salvage radiotherapy pelvic lymph node enlargement > 1 cm in short axis diameter of the abdomen and pelvis (cN1) (unless the enlarged lymph node is sampled and negative)
- •No evidence of macroscopic local recurrence or metastatic disease on pre-salvage radiotherapy MRI (with IV contrast) or multislice computed tomography (with IV and oral contrast) of the abdomen and pelvis assessed within 16 weeks prior to randomization
- •No presence or history of bone metastases (bone scan must be performed in case of clinical suspicion [e.g., bone pain])
- •Gleason score must be available
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- •Compliant and geographically proximal to allow for proper staging and follow-up
- •No prior invasive malignancy, except non-melanomatous skin cancer or other malignancies with a documented disease-free survival of ≥ 5 years
- •No bilateral hip prosthesis
- •No severe or active co-morbidity likely to impact on the advisability of dose-intensive salvage radiotherapy, including any of the following:
- •History of inflammatory bowel disease
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
- •Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- •Transmural myocardial infarction within the past 6 months
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of randomization
- •No psychiatric disorder precluding understanding of information on trial-related topics, giving informed consent, or filling out quality-of-life questionnaires
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior pelvic radiotherapy
- •No hormonal treatment or bilateral orchiectomy prior to or following prostatectomy
- •At least 4 weeks since prior and no concurrent use of products known to affect PSA levels (e.g., PC Calm, PC Plus, PC SPES, finasteride, or fluconazole)
- •At least 30 days since prior treatment in another clinical trial
- •No other concurrent anticancer treatments, including luteinizing hormone-releasing hormone (LHRH) analogues, antiandrogens, orchiectomy, or chemotherapy
- •No other concurrent investigational or experimental treatments or drugs
- •INCLUSION CRITERIA
- •Patient must give written informed consent before randomization.
- •Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy at least 12 weeks before randomization. Tumor stage pT2a-3b, R0-1, pN0 or cN0 according to the UICC TNM 2009 (see Appendix 1), Gleason score available.
- •PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises. The first value must be measured earliest 4 weeks after radical prostatectomy.
- •PSA at randomization ≤ 2 ng/mL.
- •WHO performance status 0-1 at randomization.
- •Age at randomization between 18 and 75 years.
- •Baseline QoL questionnaire (QLQ) has been completed.
- •Patient agrees not to father a child during salvage RT and during 6 months thereafter.
- •Patient compliance and geographic proximity allow proper staging and follow-up.
- •The responsible pathologist has agreed to provide sample material for central pathological review (see Section 16) and tissue banking (only if patient gave informed consent) within the specified timelines.
排除标准
- •Persistent PSA 4-20 weeks after radical prostatectomy > 0.4 ng/mL
- •Palpable prostatic fossa mass suggestive of recurrence, unless an ultrasound guided biopsy is non-malignant.
- •Pre-salvage RT pelvic lymph node enlargement > 1 cm in short axis diameter of the abdomen and pelvis (cN1), unless the enlarged lymph node is sampled and negative, and/or evidence of macroscopic local recurrence or metastatic disease on pre-salvage RT MRI (magnetic resonance imaging; with i.v. contrast) or multislice computed tomography (CT; with i.v. and oral contrast) of the abdomen and pelvis assessed within 16 weeks prior to randomization.
- •Presence or history of bone metastases. Bone scan must be performed in case of clinical suspicion (e.g. bone pain).
- •Prior invasive malignancy, except non-melanomatous skin cancer or other malignancies with a documented disease-free survival for a minimum of 5 years.
- •Hormonal treatment or bilateral orchiectomy prior to or following prostatectomy.
- •Bilateral hip prosthesis.
- •Prior pelvic radiotherapy.
- •The use of products known to affect PSA levels within 4 weeks prior to start of trial treatment (e.g. PC Calm, PC Plus, PC SPES, finasteride, fluconazole).
- •Severe or active co-morbidity likely to impact on the advisability of dose intensified salvage RT.
- •Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent or filling out QoL questionnaires.
- •Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry.
研究组 & 干预措施
Arm A: 64 Gy - Radiation Therapy
Active Comparator
Arm A: 64 Gy (32 x 2 Gy) without hormonal treatment
干预措施: radiation therapy (Radiation)
Arm B: 70 Gy - Radiation Therapy
Active Comparator
Arm B: 70 Gy (35 x 2 Gy) without hormonal treatment
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Freedom from biochemical progression
时间窗: from the day of trial randomization to the day of either first recorded biochemical progression, clinical progression or death due to clinical progression up to 10 years.
次要结局
- Prostate cancer-specific survival(time from trial randomization to the date of death due to prostate cancer up to 10 years.)
- Overall survival(time from trial randomization to the date of death from any cause up to 10 years.)
- Clinical progression-free survival(from the day of randomization to the day of the first record of either local or regional recurrence, distant recurrence, start of hormonal treatment, or death due to any cause up to 10 years.)
- Time to hormonal treatment(time from trial randomization to start of hormonal treatment up to 10 years.)
- Acute and late gastrointestinal and genitourinary toxicity according to CTCAE v 4.0(occurring during treatment and up to 3 months after completion of treatment. Late toxicity is defined as occurring later than 3 months after end of treatment.)
研究者
研究点 (28)
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