Prostate Cancer RecurrentPhase 2NCT06220188
PSMA-RLT in Biochemically Recurrent PCa
A Phase 2 study testing [177Lu]Lu-PSMA I&T in people with Prostate Cancer Recurrent, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- [177Lu]Lu-PSMA I&T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jan 2024to Jan 2027
- Phase
- Phase 2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.
- No hormonal therapy within the last 12 months or recovered testosterone levels.
- PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.
- Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.
- Patients must be able to sign Informed Consent Form.
Who cannot join
- Concomitant participation in any other interventional trial.
- Concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year.
- Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
- Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Sazan Rasul, PhD, 014040058742, sazan.rasul@meduniwien.ac.at
Sazan Rasul, PhD
About this study
Official title: [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study
Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- [177Lu]Lu-PSMA I&T
- Keywords
- [177Lu]Lu-PSMA I&T, PSMA-radioligand therapy, Biochemical recurrence, Prostate cancer, PSA value
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-PSMA I&TDrug
Also called PSMA-RLT
2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of [177Lu]Lu-PSMAI\&T radioligand therapy at 6-week intervals
| Study group | Role | What they receive |
|---|---|---|
| Biochemical recurrent prostate cancer but not radio-morphological local recurrence | Experimental | Patients with prostate cancer and confirmed biochemical recurrence with PSA of ≥ 0.2 ng/ml after radical prostatectomy or PSA > nadir + 2ng/ml after radiotherapy but not radio-morphological local recurrence after primary therapy with curative intent will receive systemic therapy with [177Lu]Lu-PSMAI\&T radioligand therapy Receives: Drug: [177Lu]Lu-PSMA I&T |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response
in term of PSA decline of ≥ 50% from baseline value
Measured: 12 months
Emergence of therapy toxicity
in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased <8.0 g/dL; <4.9 mmol/L; <80 g/L; platelet count decreased <50,000 - 25,000/mm3; <50.0 - 25.0 x 10e9 /L and white blood cell decreased <2000 - 1000/mm3; <2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased > 3.0 x baseline or >3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased >5.0 - 20.0 x ULN if baseline was normal or >5.0 - 20.0 x baseline if baseline was abnormal; albumin <2 g/dL or <20 g/L; bilirubin increased >3.0 - 10.0 x ULN if baseline was normal or >3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased > ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: 12 months
Secondary outcomes (5)
Time to PSA value progression
to evaluate progression free survival
Measured: 18 months
androgen deprivation therapy- and other treatment-free survival
analyze the time until the start of androgen deprivation therapy
Measured: 18 months
Evaluation of life quality of the treated patients
Using the questionnaires: FACT-P, EORTC QLQ
Measured: 18 months
Assess time to imaging progression
In terms of appearance of new PSMA-avid lesions and/or size progression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1.
Measured: 18 months
Quantification of circulating free tumor DNA
Quantification of circulating free tumor DNA (ctDNA), enumeration of circulating tumor cells (CTCs) before and following [177Lu]Lu-PSMAI\&T-RLT and analyse molecular changes in liquid biopsy markers following [177Lu]Lu-PSMAI\&T-RLT.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start15 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-center one-arm phase II study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sazan Rasul, MD, PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220188
- Sponsor's protocol ID
- 1938/2022
- Other IDs
- 2022-003713-11
- Status last verified
- Feb 2024
- First submitted
- 25 Dec 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study
- ClinicalTrials.gov ID
- NCT06220188
- Acronym / sponsor ID
- 1938/2022
- Conditions
- Prostate Cancer Recurrent
- Keywords
- [177Lu]Lu-PSMA I&T, PSMA-radioligand therapy, Biochemical recurrence, Prostate cancer, PSA value
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Jan 2024 (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.
Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-center one-arm phase II study
| Arm | Type | Receives |
|---|---|---|
| Biochemical recurrent prostate cancer but not radio-morphological local recurrence | Experimental | Drug: [177Lu]Lu-PSMA I&TPatients with prostate cancer and confirmed biochemical recurrence with PSA of ≥ 0.2 ng/ml after radical prostatectomy or PSA > nadir + 2ng/ml after radiotherapy but not radio-morphological local recurrence after primary therapy with curative intent will receive systemic therapy with [177Lu]Lu-PSMAI\&T radioligand therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.
- No hormonal therapy within the last 12 months or recovered testosterone levels.
- PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.
Key exclusion criteria (4 listed)
- Concomitant participation in any other interventional trial.
- Concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year.
- Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
- Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.
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 |
|---|---|---|
| [177Lu]Lu-PSMA I&TAlso: PSMA-RLT2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of [177Lu]Lu-PSMAI\&T radioligand therapy at 6-week intervals | Drug | Biochemical recurrent prostate cancer but not radio-morphological local recurrence |
Primary outcome
PSA response
Time frame: 12 months
in term of PSA decline of ≥ 50% from baseline value
Emergence of therapy toxicity
Time frame: 12 months
in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased <8.0 g/dL; <4.9 mmol/L; <80 g/L; platelet count decreased <50,000 - 25,000/mm3; <50.0 - 25.0 x 10e9 /L and white blood cell decreased <2000 - 1000/mm3; <2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased > 3.0 x baseline or >3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased >5.0 - 20.0 x ULN if baseline was normal or >5.0 - 20.0 x baseline if baseline was abnormal; albumin <2 g/dL or <20 g/L; bilirubin increased >3.0 - 10.0 x ULN if baseline was normal or >3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased > ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
5 secondary outcomes
Time to PSA value progression
Time frame: 18 months
androgen deprivation therapy- and other treatment-free survival
Time frame: 18 months
Evaluation of life quality of the treated patients
Time frame: 18 months
Assess time to imaging progression
Time frame: 18 months
Quantification of circulating free tumor DNA
Time frame: 18 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 13 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [177Lu]Lu-PSMA I&T in people with Prostate Cancer Recurrent, run by Medical University of Vienna at 1 site in Austria.
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 7 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sazan Rasul, PhD (004314040058742, sazan.rasul@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA response (time frame: 12 months). The study lists 2 primary outcomes in all. 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 13 Feb 2024.