Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

Phase 3

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.

• Registration Number: NCT04858880
• Lead Sponsor: Lund University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-09
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 374

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continued salvage radiotherapy + lymph node irradiation (non responders)	Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.	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.
Continued salvage radiotherapy (non responders)	Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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 - PR25. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm, month 12, 24, and 60.	Arms A and B will be compared regarding quality of life.

Trial Locations

Locations (3)

Jönköping County Hospital, Ryhov; 🇸🇪 Jönköping, Sweden

Kalmar County Hospital; 🇸🇪 Kalmar, Sweden

Lund University Hospital; 🇸🇪 Lund, Sweden