Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery

Inclusion Criteria

• •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
• •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.