Prostate CancerPhase 3NCT04794777
Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
A Phase 3 study testing Individualised therapy and Standard salvage therapy in people with Prostate Cancer, run by Stefan Carlsson at 5 sites in Sweden.
Trial summary
Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. 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?
- Individualised therapy and Standard salvage therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 5 sitesSweden
- Study dates
- 30 Oct 2018to 30 Oct 2027
- Phase
- Phase 3
- 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
- Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA >0.2 <2.0 ng/mL, and increasing measured twice.
- Multidisciplinary conference (MDK) decision to offer the patient SRT
- Signed Informed Consent
Who cannot join
- Patients previously treated for prostate cancer with biochemical recurrence
- Previous treatment with androgen deprivation therapy (ADT) after surgery
- Previous pelvic radiotherapy
- Patients with positive lymph nodes at surgery
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yvonne Larsen contact
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Göteborg, 413 45
Ola Bratt, ola.bratt@vgregion.se
Jon Kindblom, jon.kindblom@vgregion.se
- Not yet recruiting
Örebro University Hospital
Örebro, Örebro County, 701 85
Janusz Frey, MD PhD, janusz.frey@regionorebrolan.se
Anna Messing-Eriksson, anna.messing-eriksson@regionorebrolan.se
- Not yet recruiting
Södersjukhuset
Stockholm, Stockholm County, 118 83
Chunde Li, Chunde.Li@ki.se
Gunilla Sellerstam, gunilla.sellerstam@sll.se
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 171 76
Stefan Carlsson, stefan.carlsson@ki.se
Katarina Hammarlund, katarina.hammarlund@sll.se
- Not yet recruiting
Norrland's University Hospital
Umeå, 901 85
Karin Söderkvist, MD, karin.soderkvist@umu.se
Camilla Thellenberg, camilla.thellenberg@umu.se
About this study
Official title: A Randomized Trial Comparing Conventional "Salvage" Radiotherapy and Individualized 68Ga-PSMA-11 or 18F-PSMA-1007 PET/CT Targeted Treatment in Patients With Biochemical Recurrence After Prostate Cancer Surgery
Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT.
Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact.
In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.
- Conditions
- Prostate Cancer
- Being tested
- Individualised therapy, Standard salvage therapy
- Keywords
- PSMA PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised therapyCombination product
Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed.
Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND).
Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND.
Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention.
Standard salvage therapyRadiation
Standard salvage radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Individualised therapy based on results of the PSMA PET/CT. Receives: Combination Product: Individualised therapy |
| Control arm | Active comparator | Standard salvage therapy. Results of PSMA PET/CT blinded. Receives: Radiation: Standard salvage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PSA progression free survival
Number of patients with progress defined by Prostate-Specific Antigen (PSA) measurement
Measured: Throughout the study, approximately 10 years.
Secondary outcomes (4)
Time to metastasis
Time to documented metastasis of prostate cancer
Measured: At 5, 7 and 10 years
Prostate cancer specific survival
Time to prostate cancer specific death
Measured: At 5, 7 and 10 years
Time to secondary treatment
Time to need for secondary treatment for prostate cancer
Measured: At 5, 7 and 10 years
Differences in quality of life recorded using Patient Reported Outcome Measure (PROM)
A modified version of the PSMA questionnaire developed by the National Prostate Cancer Register. Scale from 1 to 5 were 1 is very good and 5 is very bad.
Measured: Baseline, 6, 12, 36 and 60 months after completed treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start30 Oct 2018
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Carlsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Carlsson, Karolinska University Hospital
- Investigators
- Stefan Carlsson, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794777
- Sponsor's protocol ID
- PSMA recidiv
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Conventional "Salvage" Radiotherapy and Individualized 68Ga-PSMA-11 or 18F-PSMA-1007 PET/CT Targeted Treatment in Patients With Biochemical Recurrence After Prostate Cancer Surgery
- ClinicalTrials.gov ID
- NCT04794777
- Acronym / sponsor ID
- PSMA recidiv
- Conditions
- Prostate Cancer
- Keywords
- PSMA PET/CT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Stefan CarlssonUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 Mar 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.
Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT.
Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact.
In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Combination Product: Individualised therapyIndividualised therapy based on results of the PSMA PET/CT. |
| Control arm | Active comparator | Radiation: Standard salvage therapyStandard salvage therapy. Results of PSMA PET/CT blinded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA >0.2 <2.0 ng/mL, and increasing measured twice.
- Multidisciplinary conference (MDK) decision to offer the patient SRT
- Signed Informed Consent
Key exclusion criteria (4 listed)
- Patients previously treated for prostate cancer with biochemical recurrence
- Previous treatment with androgen deprivation therapy (ADT) after surgery
- Previous pelvic radiotherapy
- Patients with positive lymph nodes at surgery
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 |
|---|---|---|
| Individualised therapyGroup I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed. Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND). Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND. Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention. | Combination product | Experimental arm |
| Standard salvage therapyStandard salvage radiotherapy | Radiation | Control arm |
Primary outcome
Primary PSA progression free survival
Time frame: Throughout the study, approximately 10 years.
Number of patients with progress defined by Prostate-Specific Antigen (PSA) measurement
4 secondary outcomes
Time to metastasis
Time frame: At 5, 7 and 10 years
Prostate cancer specific survival
Time frame: At 5, 7 and 10 years
Time to secondary treatment
Time frame: At 5, 7 and 10 years
Differences in quality of life recorded using Patient Reported Outcome Measure (PROM)
Time frame: Baseline, 6, 12, 36 and 60 months after completed treatment.
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 20 Mar 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.
Yvonne Larsen contact
Stefan Carlsson principal investigator
Karolinska University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Individualised therapy and Standard salvage therapy in people with Prostate Cancer, run by Stefan Carlsson at 5 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 3 inclusion and 4 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stefan Carlsson (0704871106 ext. 46, stefan.carlsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary PSA progression free survival (time frame: Throughout the study, approximately 10 years.). 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 20 Mar 2025.