Clinical trial NCT04858880: Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Official title: Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
Prostate-Specific Antigen PSA
PSA
Radiation
Lymph node radiation
Prostate cancer recurrence
Randomized trial
Prostatic Neoplasms
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 374
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Failure-free survival (FFS).
timeFrame: 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
Secondary outcomes:
measure: Systemic treatment-free survival.
timeFrame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
measure: Distant metastasis-free survival.
timeFrame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
measure: Prostate cancer specific survival.
timeFrame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
measure: Overall survival.
timeFrame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
measure: Numbers of patients with acute toxicity (≤ 3 months after end of salvage radiotherapy).
timeFrame: Up to 3 months after end of salvage radiotherapy.
measure: Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy).
timeFrame: After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy.
measure: Patients self-esteem of quality of life.
timeFrame: 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.
measure: Patients self-esteem of quality of life.
timeFrame: 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.
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Jönköping County Hospital, Ryhov
city: Kalmar
country: Sweden
facility: Kalmar County Hospital
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
References: