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Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorLund University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Life expectancy > 10 years

Age ≥18 years.

World Health Organization (WHO) performance status 0-1.

Estimated life expectancy >10 years.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.

    Radiation

    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.

Treatment groups

374 Participants
are divided into 3 treatment groups
Group A: Continued salvage radiotherapy + lymph node irradiation (non responders)Experimental treatment 1 intervention
Group B: Continued salvage radiotherapy (non responders)Active comparator 1 intervention
Group C: Continued salvage radiotherapy (responders)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Failure-free survival (FFS).

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.

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 outcomes

1

Systemic treatment-free survival.

Arms A and B will be compared regarding 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).
2

Distant metastasis-free survival.

Arms A and B will be compared regarding distant metastasis-free survival. survival.

Time frame
Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
3

Prostate cancer specific survival.

Arms A and B will be compared regarding prostate cancer specific survival survival.

Time frame
Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
4

Overall survival.

Arms A and B will be compared regarding 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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University Hospital

Lead sponsor

Source ClinicalTrials.gov
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