Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT04858880

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

Led by Lund University Hospital · Updated on 2025-09-16

374

Participants Needed

3

Research Sites

468 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Life expectancy greater than 10 years
  • Age 18 years or older
  • WHO performance status of 0 or 1
  • Histological evidence of prostate cancer in prostatectomy specimen
  • Pathologically node-negative primary tumor (pT), no distant metastasis (M0)
  • Biochemical recurrence after prostatectomy with PSA between 0.15 and less than 0.70 ng/ml
  • Ability to comply with the study protocol
  • Signed informed consent
  • Adequate lab results: hemoglobin above 90 g/L, neutrophils above 1.0 x 10^9/L, platelets above 75 x 10^9/L, bilirubin below 1.5 times upper limit of normal, ALAT below 5 times upper limit of normal, creatinine below 1.5 times upper limit of normal
Not Eligible

You will not qualify if you...

  • Presence of regional lymph node or distant metastases diagnosed by imaging
  • Prior or ongoing hormonal therapy such as antiandrogens or gonadotropin releasing hormone
  • Previous radiotherapy to the pelvis
  • Prior malignancy other than prostate cancer or basalioma within the past five years
  • Clinically significant active cardiovascular disease, including myocardial infarction within 6 months, unstable angina, or NYHA class III-IV heart failure
  • Severe pulmonary disease
  • Any other serious or uncontrolled illness that would make participation undesirable according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Jönköping County Hospital, Ryhov

Jönköping, Sweden, 551 85

Actively Recruiting

2

Kalmar County Hospital

Kalmar, Sweden, 391 26

Actively Recruiting

3

Lund University Hospital

Lund, Sweden, 221 85

Actively Recruiting

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Research Team

A

Adalsteinn Gunnlaugsson, MD, PhD

CONTACT

J

Jan Sundberg, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy. | DecenTrialz