Prostate CancerALSO-PERFORMNCT07863336
ALSO-PERFORM Study. ALternating Stereotaxic Or PElvic Radiotherapy FOR Metachronic Metastatic Prostate Cancer
An observational study of Prostate Cancer, run by Amsterdam UMC, location VUmc.
Trial summary
Outcome of metastasis directed therapy Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with histologically confirmed prostate cancer who have undergone radical prostatectomy, have experienced biochemical (PSA) recurrence, and have lymphogenic metastases in the pelvic region on PSMA PET/CT.
Who may be able to join
- Men with histologically confirmed prostate cancer
- Men who have undergone radical prostatectomy (RP), with or without extended pelvic lymph node dissection (ePLND)
- Men with pNx or pN0 status in the ePLND specimen
- Biochemical recurrence after RP (PSA > 0.2 ng/mL on two occasions)
- Evidence of lymphogenic metastases on staging PSMA PET/CT within the pelvis (below the aortic bifurcation)
- Life expectancy ≥ 5 years, as estimated by the treating physician
Who cannot join
- Previous salvage radiotherapy to the prostate bed
- Men with lymph node metastases outside the pelvis (M1a)
- Men with osseous metastases (M1b) or visceral metastases (M1c)
- Men with lymphogenic metastases and a local recurrence
- Men with inguinal metastases
- Previous treatment in the pelvic region, such as treatment of the bladder or rectum, that precludes radiotherapy to the pelvis
- Previous treatment with an LHRH agonist/antagonist within 6 months prior to study inclusion. Patients must have normal testosterone levels (testosterone > 7.0 nmol/L)
About this study
Official title: ALSO-PERFORM Study: ALternating Stereotaxic Or PElvic Radiotherapy FOR Metachronic Metastatic Prostate Cancer
Outcome of metastasis directed therapy
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the number of patients (and percentage of the total) with metastases on PSMA PET/CT two years after study initiation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Accord Healthcare, Inc.
- Responsible party
- Principal investigator, Prof. Dr. André N. Vis, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863336
- Sponsor's protocol ID
- 2025.0366
- Acronym
- ALSO-PERFORM
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALSO-PERFORM Study: ALternating Stereotaxic Or PElvic Radiotherapy FOR Metachronic Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07863336
- Acronym / sponsor ID
- ALSO-PERFORM / 2025.0366
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Accord Healthcare, Inc.
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Oct 2026 (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.
Outcome of metastasis directed therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with histologically confirmed prostate cancer who have undergone radical prostatectomy, have experienced biochemical (PSA) recurrence, and have lymphogenic metastases in the pelvic region on PSMA PET/CT.
Key inclusion criteria (6 listed)
- Men with histologically confirmed prostate cancer
- Men who have undergone radical prostatectomy (RP), with or without extended pelvic lymph node dissection (ePLND)
- Men with pNx or pN0 status in the ePLND specimen
- Biochemical recurrence after RP (PSA > 0.2 ng/mL on two occasions)
- Evidence of lymphogenic metastases on staging PSMA PET/CT within the pelvis (below the aortic bifurcation)
Key exclusion criteria (7 listed)
- Previous salvage radiotherapy to the prostate bed
- Men with lymph node metastases outside the pelvis (M1a)
- Men with osseous metastases (M1b) or visceral metastases (M1c)
- Men with lymphogenic metastases and a local recurrence
- Men with inguinal metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is the number of patients (and percentage of the total) with metastases on PSMA PET/CT two years after study initiation.
Time frame: 24 months
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 8 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Amsterdam UMC, location VUmc.
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 6 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the number of patients (and percentage of the total) with metastases on PSMA PET/CT two years after study initiation. (time frame: 24 months). 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 8 Oct 2026.