NCT04794777 Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
| NCT ID | NCT04794777 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stefan Carlsson |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2018-10-30 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2018-10-30 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Stefan Carlsson
PRINCIPAL INVESTIGATOR
Karolinska University Hospital
Frequently Asked Questions
Who can join the NCT04794777 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04794777 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT04794777 currently recruiting?
Yes, NCT04794777 is actively recruiting participants. Contact the research team at stefan.carlsson@ki.se for enrollment information.
Where is the NCT04794777 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Stockholm, Sweden, Stockholm, Sweden, Umeå, Sweden and 1 additional location.
Who is sponsoring the NCT04794777 clinical trial?
NCT04794777 is sponsored by Stefan Carlsson. The principal investigator is Stefan Carlsson at Karolinska University Hospital. The trial plans to enroll 450 participants.
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