Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery

Korábbi kezelés

• 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.
• Hormonal treatment or bilateral orchiectomy prior to or following prostatectomy.
• 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).
• Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry.

Más betegség

• Palpable prostatic fossa mass suggestive of recurrence, unless an ultrasound guided biopsy is non-malignant.
• 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.
• Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent or filling out QoL questionnaires.

Egyéb

• Persistent PSA 4-20 weeks after radical prostatectomy > 0.4 ng/mL
• Bilateral hip prosthesis.
• Severe or active co-morbidity likely to impact on the advisability of dose intensified salvage RT.

• 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.

A regiszterben nem jelölt feltételek

• 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