Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery
This trial is active, not recruiting.
|Sponsor||Swiss Group for Clinical Cancer Research|
|Start date||January 2011|
|End date||July 2016|
|Trial size||350 participants|
|Trial identifier||NCT01272050, CDR0000691926, EU-21088, SAKK 09/10, SWS-SAKK-09/10|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Antwerpen, Belgium||Ziekenhuis Netwerk Antwerpen Middelheim||no longer recruiting|
|Ghent, Belgium||Ghent University Hospital||no longer recruiting|
|Ghent, Belgium||St. Lukas Hospital Ghent||no longer recruiting|
|Aachen, Germany||Universitaetsklinikum Aachen, Klinik für Strahlentherapie||no longer recruiting|
|Berlin, Germany||Charite University Hospital - Campus Virchow Klinikum||no longer recruiting|
|Dresden, Germany||University Hospital and Medical Faculty Technical University of Dresden||no longer recruiting|
|Essen, Germany||Universitaetsklinikum Essen, Klinik für Strahlentherapie||no longer recruiting|
|Homburg/Saar, Germany||Universitätsklinikum Saarland||no longer recruiting|
|Munich, Germany||Klinikum der LMU Muenchen||no longer recruiting|
|Munich, Germany||Technische Universitaet Muenchen||no longer recruiting|
|Regensburg, Germany||Klinikum der Universitaet Regensburg||no longer recruiting|
|Rostock, Germany||Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock||no longer recruiting|
|Tuebingen, Germany||Universitaet Tuebingen||no longer recruiting|
|Wuerzburg, Germany||Klinik fuer Strahlentherapie Universitaet Wuerzburg||no longer recruiting|
|Aarau, Switzerland||Kantonsspital Aarau||no longer recruiting|
|Basel, Switzerland||Universitaetsspital-Basel||no longer recruiting|
|Bellinzona, Switzerland||Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli||no longer recruiting|
|Bern, Switzerland||Inselspital Bern||no longer recruiting|
|Biel, Switzerland||Radio-Onkologiezentrum Biel-Seeland-Berner Jura AG||no longer recruiting|
|Chur, Switzerland||Kantonsspital Graubuenden||no longer recruiting|
|Luzern, Switzerland||Kantonsspital Luzern||no longer recruiting|
|Muensterlingen, Switzerland||Kantonsspital Muensterlingen||no longer recruiting|
|Sion, Switzerland||Hopital de Sion||no longer recruiting|
|St. Gallen, Switzerland||Kantonsspital - St. Gallen||no longer recruiting|
|Thun, Switzerland||Radio-Onkologie Berner Oberland AG||no longer recruiting|
|Zurich, Switzerland||Klinik Hirslanden||no longer recruiting|
|Zurich, Switzerland||City Hospital Triemli||no longer recruiting|
|Zurich, Switzerland||UniversitaetsSpital Zuerich||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
Freedom from biochemical progression
time frame: from the day of trial randomization to the day of either first recorded biochemical progression, or death due to clinical progression.
Clinical progression-free survival
time frame: 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
Time to hormonal treatment
time frame: time from trial randomization to start of hormonal treatment
Prostate cancer-specific survival
time frame: time from trial randomization to the date of death due to prostate cancer
time frame: time from trial randomization to the date of death from any cause
Acute and late gastrointestinal and genitourinary toxicity according to CTCAE v 4.0
time frame: 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.
Male participants from 18 years up to 75 years old.
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. EXCLUSION CRITERIA - 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.
|Official title||Dose Intensified Salvage Radiotherapy in Biochemically Relapsed Prostate Cancer Without Macroscopic Disease. A Randomized Phase III Trial.|
|Description||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. Patients complete quality-of-life questionnaires at baseline and at 3, 12, 24, 36, 48, and 60 months after completing study therapy. After completion of study treatment, patients are followed every 6 months for 3 years and then every 12 months for up to 10 years.|
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