Could extra radiation spots stop prostate Cancer's return?

NCT ID NCT04858880

Disease control Sponsor: Lund University Hospital Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase III trial tests whether adding radiation to the lymph nodes improves outcomes for men whose prostate cancer has returned after prostatectomy, indicated by a rising PSA. About 374 participants with low PSA levels will receive either standard radiation to the prostate bed or a personalized plan that also targets lymph nodes if PSA doesn't drop quickly. The goal is to see if this approach extends the time before cancer progresses or requires systemic therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Radiation therapy (prostate bed with or without lymph node irradiation)
What this could lead to: If successful, this could establish a more effective radiotherapy approach for men whose prostate cancer returns after surgery, potentially delaying the need for systemic treatments.
What could go wrong: This is a phase III trial, but results are not yet available. Adding lymph node radiation may increase side effects without improving outcomes, and the benefit may be limited to certain patients.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 374 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could extra radiation spots stop prostate Cancer's return?

What the study statuses mean