Prostate Cancer
Conditions
Keywords
Prostate cancer, Prostate-Specific Antigen PSA, PSA, Radiation, Lymph node radiation, Prostate cancer recurrence, Randomized trial, Prostatic Neoplasms
Brief summary
A randomized phase III trial to study the effect of adding lymph node irradiation in patients with poor prostate-specific antigen (PSA) response during salvage radiotherapy for biochemical recurrence (0.15 ≤ PSA \<0.70 ng/ml) after prostatectomy.
Interventions
RADIATIONRadiation to the prostate bed with or without addition of radiation of lymph node irradiation.
Radiation to the prostate bed with or without addition of radiation of lymph node irradiation (non responders). Patients with PSA response continues radiotherapy as initially planned, and are not followed according to the study protocol, only according to clinical practice.
Sponsors
Lund University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Life expectancy \> 10 years * Age ≥18 years. * World Health Organization (WHO) performance status 0-1. * Estimated life expectancy \>10 years. * Histological evidence of prostate cancer in the prostatectomy specimen * Primary tumor, regional nodes, metastasis (TNM): any primary tumor (pT), pathologically node-negative (pN0), M0. * Biochemical Recurrence (BCR) after prostatectomy, with 0.15 ≤ PSA \<0.70 ng/ml. * Patients must be able to comply with the protocol. * Signed informed consent. * Adequate laboratory findings (Haemoglobin (Hb) \>90g/L, absolute neutrophil count \>1.0x109/L, platelets \>75x109/l, bilirubin \<1.5x upper limit of normal (ULN), alanine aminotransferase (ALAT) \<5x ULN and creatinine \<1.5 ULN).
Exclusion criteria
* Metastases (regional lymph nodes or distant)\* diagnosed with imaging. * Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone). * Prior radiotherapy to the pelvis. * Prior malignancy other than prostate cancer and basalioma in the past five years. * Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) class III-IV congestive heart failure. * Severe pulmonary disease. * Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival (FFS). | FFS after SRT, with failure defined as either biochemical or clinical recurrence (imaging or biopsy confirmed). FFS is calculated from the randomization date (arms A and B) until end of follow up (month 60 after | Failure-free survival after salvage radiotherapy (SRT), with failure defined as either biochemical, defined as verified PSA level of ≥ 0.2 ng/ml above the post-radiotherapy PSA nadir value or clinical Recurrence, imaging or biopsy confirmed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant metastasis-free survival. | Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy). | Arms A and B will be compared regarding distant metastasis-free survival. survival. |
| Prostate cancer specific survival. | Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy). | Arms A and B will be compared regarding prostate cancer specific survival survival. |
| Overall survival. | Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy). | Arms A and B will be compared regarding overall survival. |
| Systemic treatment-free survival. | Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy). | Arms A and B will be compared regarding systemic treatment-free survival. |
| Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy). | After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy. | Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity. |
| Patients self-esteem of quality of life. | Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ-C30. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm B), month 12, 24, and 60. | Arms A and B will be compared regarding quality of life. |
| Numbers of patients with acute toxicity (≤ 3 months after end of salvage radiotherapy). | Up to 3 months after end of salvage radiotherapy. | Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity. |
Countries
Sweden
Contacts
Primary ContactAdalsteinn Gunnlaugsson, MD, PhD
Backup ContactJan Sundberg, RN
Outcome results
None listed