Prostate CancerPROPER2NCT04858880
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
A study testing Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. in people with Prostate Cancer, run by Lund University Hospital at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 3 sitesSweden
- Study dates
- 9 Apr 2021to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Jönköping County Hospital, Ryhov
Jönköping, 551 85
Kirsten Björnlinger, MD, +46 10 241 00 00, kirsten.bjornlinger@rjl.se
Kirsten Björnlinger, MD
- Recruiting
Kalmar County Hospital
Kalmar, 391 26
Nandor Vass, MD, +46 480 84 000, nandor.vass@regionkalmar.se
Nandor Vass, MD
- Recruiting
Lund University Hospital
Lund, 221 85
Adalsteinn Gunnlaugsson, MD, PhD, +46 46 17 75 20, adalsteinn.gunnlaugsson@skane.se
Jan Sundberg, RN, +46 46 17 70 34, jan.sundberg@skane.se
About this study
Official title: Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
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
- Prostate Cancer
- Being tested
- Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
- Keywords
- Prostate cancer, Prostate-Specific Antigen PSA, PSA, Radiation, Lymph node radiation, Prostate cancer recurrence, Randomized trial, Prostatic Neoplasms
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Continued salvage radiotherapy + lymph node irradiation (non responders) | Experimental | Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy. Receives: Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. |
| Continued salvage radiotherapy (non responders) | Active comparator | Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy. Receives: Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. |
| Continued salvage radiotherapy (responders) | No intervention | Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
Systemic treatment-free survival.
Arms A and B will be compared regarding systemic treatment-free survival.
Measured: 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.
Arms A and B will be compared regarding distant metastasis-free survival. survival.
Measured: 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.
Arms A and B will be compared regarding prostate cancer specific survival survival.
Measured: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Overall survival.
Arms A and B will be compared regarding overall survival.
Measured: 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).
Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity.
Measured: 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).
Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity.
Measured: 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.
Arms A and B will be compared regarding quality of life.
Measured: 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.
Arms A and B will be compared regarding quality of life.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start9 Apr 2021
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858880
- Sponsor's protocol ID
- PRO-02
- Acronym
- PROPER2
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
- ClinicalTrials.gov ID
- NCT04858880
- Acronym / sponsor ID
- PROPER2 / PRO-02
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostate-Specific Antigen PSA, PSA, Radiation, Lymph node radiation, Prostate cancer recurrence, Randomized trial, Prostatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continued salvage radiotherapy + lymph node irradiation (non responders) | Experimental | Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy. |
| Continued salvage radiotherapy (non responders) | Active comparator | Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy. |
| Continued salvage radiotherapy (responders) | No intervention | –Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Continued salvage radiotherapy (non responders), Continued salvage radiotherapy + lymph node irradiation (non responders) |
Primary outcome
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
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.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. in people with Prostate Cancer, run by Lund University Hospital at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adalsteinn Gunnlaugsson, MD, PhD (+46 46 17 75 20, adalsteinn.gunnlaugsson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.