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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continued salvage radiotherapy + lymph node irradiation (non responders) | Experimental | Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy. |
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| Continued salvage radiotherapy (non responders) | Active Comparator | Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy. |
|
| Continued salvage radiotherapy (responders) | No Intervention | Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival (FFS). | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic treatment-free survival. | Arms A and B will be compared regarding 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). |
| Distant metastasis-free survival. |
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Inclusion Criteria:
Exclusion Criteria:
Only patients with prostate cancer are eligible.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adalsteinn Gunnlaugsson, MD, PhD | Contact | +46 46 17 75 20 | adalsteinn.gunnlaugsson@skane.se | |
| Jan Sundberg, RN | Contact | +46 4617 70 34 | jan.sundberg@skane.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jönköping County Hospital, Ryhov | Recruiting | Jönköping | 551 85 | Sweden |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Arms A and B will be compared regarding distant metastasis-free survival. survival. |
| Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy). |
| Prostate cancer specific survival. | Arms A and B will be compared regarding prostate cancer specific survival survival. | Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy). |
| Overall survival. | Arms A and B will be compared regarding overall survival. | Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy). |
| Numbers of patients with acute toxicity (≤ 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. | Up to 3 months after end of salvage radiotherapy. |
| Numbers of patients with late toxicity (> 3 months to 5 years 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. | After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy. |
| Patients self-esteem of quality of life. | Arms A and B will be compared regarding 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. |
| Patients self-esteem of quality of life. | Arms A and B will be compared regarding quality of life. | Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ - PR25. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm, month 12, 24, and 60. |
| Kalmar County Hospital | Recruiting | Kalmar | 391 26 | Sweden |
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| Lund University Hospital | Recruiting | Lund | 221 85 | Sweden |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |