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Recruiting NCT04858880

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation..
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.

Overview

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

  • Radiation Radiation 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.

Primary outcome measures

  • Failure-free survival (FFS). [Time frame: 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 outcome measures (8)
  • Systemic treatment-free survival. [Time frame: 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. [Time frame: 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. [Time frame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).]
  • Overall survival. [Time frame: 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). [Time frame: 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). [Time frame: 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. [Time frame: 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. [Time frame: 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 3 centers
  • Jönköping County Hospital, Ryhov — Jönköping
  • Kalmar County Hospital — Kalmar
  • Lund University Hospital — Lund

Identifiers

NCT: NCT04858880 · PRO-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗