Castration-resistant Prostate CancerPhase 1PROGNOSTICSNCT06343038
Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study
A Phase 1 study testing Injection, 161Tb-SibuDAB,1GBq, Injection, 177Lu-PSMA-I&T, 1GBq and Injection, 161Tb-SibuDAB, Dose Escalation in people with Castration-resistant Prostate Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- Injection, 161Tb-SibuDAB,1GBq, Injection, 177Lu-PSMA-I&T, 1GBq and Injection, 161Tb-SibuDAB, Dose Escalation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Feb 2024to Jun 2028
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent form signed
- Male patients with age > 18 years
- Clinical indication for RLT with 177Lu-PSMA-I\&T (progressive PSMA-positive mCRPC patients after androgen receptor signalling pathway inhibitor and taxan-based chemotherapy or patient unfit for chemotherapy)
- Patients will be included in Phase Ia while being under active therapy with 177Lu-PSMA-I\&T (SoC) and after they have completed the first two cycles of 177Lu-PSMA-I\&T RLT
- At least 3 measurable tumours on PSMA PET/CT (>1.5 cm) with sufficiently intense PSMA uptake (SUVmax>20)
- ECOG Performance status: 0-1
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- Blood parameters: a) Leucocytes ≥ 3 G/L; b) Haemoglobin ≥ 100 g/L; c) Thrombocytes ≥ 100 G/L
- Estimated glomerular filtration rate (eGFR) > 45 ml/min
- Albumin > 25 g/L
- ALT, AST, AP: ≤ 5 times upper standard value
- Bilirubin ≤ 2 times upper standard value
- For male patients who are not surgically sterilized (orchiectomy or vasectomy), appropriate contraceptive measures must be taken during RLT and until 4 months after completion of RLT. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)
Who cannot join
- Prior PSMA-targeted RLT (except for the 2 first cycles in Part Ia)
- PSMA-negative (or PSMA-negative / FDG-positive) disease
- Known intolerance against DOTA, DOTAGA, urea-based analogues or against any of the components/formulation of 177Lu-PSMA-I\&T or 161Tb-SibuDAB solutions.
- Ongoing infection at the screening visit or a serious infection in the past 4 weeks
- Administration of another investigational product in the last 60 days before Visit 1 Day 1
- Prior or planed administration of a therapeutic radiopharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
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- Any extensive radiotherapy involving bone marrow over the last 3 months before inclusion to the study
- Chemotherapy in the last 4 weeks before inclusion
- Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus [HbA1c ≥ 9%], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.
- Current history of any malignancy other than prostate cancer within 5 years of enrolment except for fully resected non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Alin Chirindel, MD, +41 61 328 63 75, alin.chirindel@usb.ch
Guillaume Nicolas, MD, +41 61 265 47 02, guillaume.nicolas@usb.ch
About this study
Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.
In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.
Read more
The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.
The performance of different prostate cancer diagnostic methods is also in scope of the study.
Read the detailed description
Radioligand therapy (RLT) has emerged as an effective treatment of metastatic, castration resistant prostate cancer (mCRPC) for those patients having, prostate-specific membrane antigen (PSMA)-positive disease. This led to the FDA approval of 177Lu-PSMA-617 (PluvictoTM), a PSMA ligand radiolabelled with the β--particle emitter lutetium-177(177Lu). Despite the success of this treatment modality, the therapeutic response after RLT with 177Lu-based PSMA radioligands is limited and disease relapse inevitable. In addition, approximately 1/3 of the patients does not respond to 177Lu-based RLT despite PSMA-positive mCRPC.
It has been hypothesized that the insufficient absorbed dose delivery to macroscopic tumours and, in particular, to microscopic metastases with currently used 177Lu-based PSMA radioligands is the reason for the treatment failure in these patients. SibuDAB, a novel long-circulating PSMA ligand, was successfully tested in the preclinical setting in combination with terbium-161 (161Tb) that emits not only β--particles but also conversion and Auger electrons and, hence, delivers 2-4 times higher absorbed doses to microscopic tumours than 177Lu.
The researchers, therefore, propose to enhance the efficacy of PSMA-targeting RLT by using the long-circulating ligand (SibuDAB) labelled with 161Tb. The researchers expect 161Tb-SibuDAB to exhibit increased and/or prolonged tumour uptake with a higher deposition of energy (due to short ranged Auger electrons) resulting in a high linear energy transfer (LET) and, hence, relative biological effectiveness. 161Tb-SibuDAB should not only deliver the absorbed dose to the cellular nucleus (via β-- radiation) but also to the cell membrane and organelles (through the emission of conversion and Auger electrons) which, in mathematical models, leads to a 3-4-fold increased absorbed dose to single cancer cells compared to standard RLT.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- Injection, 161Tb-SibuDAB,1GBq, Injection, 177Lu-PSMA-I&T, 1GBq, Injection, 161Tb-SibuDAB, Dose Escalation
- Keywords
- Radioligand Therapy, Phase Ia/Ib, Circulating Tumour Cells, Biomarkers Development, Voxel-based 3D Dosimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection, 161Tb-SibuDAB,1GBqDrug
Intravenous injection via peripheral venous catheter of ~1GBq 161Tb-SibuDAB (~200 μg / ~125 nM) in saline
Injection, 177Lu-PSMA-I&T, 1GBqDrug
Intravenous injection via peripheral venous catheter of ~1GBq 161Tb-SibuDAB (~100 μg / ~65 nM) in saline
Injection, 161Tb-SibuDAB, Dose EscalationDrug
Intravenous injection via peripheral venous catheter of 161Tb-SibuDAB in saline. The intervention comprises 4 cycles at 6-week intervals.
The 161Tb-SibuDAB entry activity will be calculated based on dosimetry and toxicity data from the first 3 patients in Phase Ia of the study.
The escalated or de-escalated 161Tb-SibuDAB activity for the subsequent 3-patient cohorts will be determined based on the clinical and biochemical safety information and on organ dosimetry results of the entry/previous cohort. Up to 4 escalation or de-escalation steps will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Over Group A | Active comparator | Cross-over design (n=10, random allocation at a 1:1 ratio). Event order:
1. Injection of 1 GBq of 161Tb-SibuDAB,
2. 3 weeks washout period,
3. Injection of 1GBq of 177Lu-PSMA-I\&T Receives: Drug: Injection, 161Tb-SibuDAB,1GBq; Drug: Injection, 177Lu-PSMA-I&T, 1GBq |
| Cross-Over Group B | Active comparator | Cross-over design (n=10, random allocation at a 1:1 ratio). Event order:
1. Injection of 1 GBq of 177Lu-PSMA-I\&T,
2. 3 weeks washout period,
3. Injection of 1GBq of 161Tb-SibuDAB Receives: Drug: Injection, 161Tb-SibuDAB,1GBq; Drug: Injection, 177Lu-PSMA-I&T, 1GBq |
| Dose Escalation Study | Experimental | Arm composed of 5 patient cohorts each with 3-patients. Treatment consists of 4 cycles of 161Tb-SibuDAB based on the available MTD and DLT findings. Safety and efficacy evaluation performed after each therapy cycle. Receives: Drug: Injection, 161Tb-SibuDAB, Dose Escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Tumour absorbed dose
Comparison of median tumour absorbed dose, in Gy, after sequential injections of non-therapeutic test activity of 161Tb-SibuDAB and 177Lu-PSMA I\&T in the same patients.
Tumour absorbed dose is obtained by SPECT/CT of head, thorax, abdomen and pelvis and represents the time integrated tumour activity (3 tumours per patient). To avoid carry-over effects, a period of at least 21 days will be allowed between the two consecutive test injections.
Measured: 3, 24, 48 and 168 hours after each injection
Phase Ib: Identification of the optimal biological dose of 161Tb-SibuDAB for mCRPC RLT
Identification of the optimal biological dose of 161Tb-SibuDAB, in GBq, for mCRPC RLT. The optimal maximum tolerated dose / biological dose will be the highest 161Tb-SibuDAB injected activity which elicits a clinically relevant adverse event grade G3 (according to CTCAE 5.0, ranging from G1 to G5 where G1 corresponds to mild AE and and G5 corresponds to AE related death) in maximal 1 patient per cohort / 1 patient in two cohorts.
Measured: baseline and 1 week, 2 weeks and 4 weeks after each injection. Long term: 6 and 12 months after RLT
Secondary outcomes (4)
Phase Ia: Estimation of critical organ median absorbed doses
Estimation of critical organ (bone marrow, kidney, salivary gland) median absorbed doses after injection of a non-therapeutic test activity of 161Tb-SibuDAB and 177Lu-PSMA I\&T in the same patients. Critical organ absorbed dose is obtained by SPECT/CT of head, thorax, abdomen and pelvis and represents the time integrated tumour activity (3 tumours per patient). Blood samples are collected at each timepoint to enable bone marrow dosimetry.
Measured: 3, 24, 48 and 168 hours after each injection
Phase Ia: Estimation of the median tumour-to-critical organ absorbed dose ratios
Estimation of the median tumour-to-critical organ absorbed dose ratios after test activity injections of 161Tb-SibuDAB and 177Lu-PSMA-I\&T in same patient. The potential therapeutic index will be calculated by take the simple ratio between the median tumour doses (Outcome 1) and the corresponding critical organ doses (Outcome 3) in each patient.
Measured: 3, 24, 48 and 168 hours after each injection
Phase Ib: Cumulative median tumour and organ absorbed doses after 4 cycles of 161Tb-SibuDAB RLT
The median cumulative tumour absorbed dose will represent the 4-cycle summation of the median tumour absorbed dose after receiving the therapeutic injected activity of 161Tb-SibuDAB. This will be normalized to the injected activity (expressed as Gy/GBq).
Measured: 3, 24, 48 and 168 hours after each injection
Phase Ib: Estimation of the "therapy index" for 161Tb-SibuDAB RLT.
Simple radios will be calculated between the cumulative median tumour absorbed dose and the cumulative median doses of different critical organs following completion of 161Tb-SibuDAB RLT. The "therapy index" will be identified as the lowest value for the calculated ratios.
Measured: 3, 24, 48 and 168 hours after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start20 Feb 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In Phase Ia: Radiation dosimetry driven, head-to-head in cross-over design comparison of tumour and critical organ absorbed doses after sequential non-therapeutic injections of 161Tb-SibuDAB and 177Lu-PSMA-I\&T in the same mCRPC patients undergoing standard 177Lu-PSMA-I\&T RLT. In Phase Ib: Clinical and radiation dosimetry-based dose escalation study, with a classical 3+3 design, to identify the optimal biologic dose (injected activity) of 161Tb-SibuDAB for safe and effective RLT.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alin Chirindel, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343038
- Sponsor's protocol ID
- 2023-01868; th23Nicolas
- Other IDs
- 2023
- Acronym
- PROGNOSTICS
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study
- ClinicalTrials.gov ID
- NCT06343038
- Acronym / sponsor ID
- PROGNOSTICS / 2023-01868; th23Nicolas
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- Radioligand Therapy, Phase Ia/Ib, Circulating Tumour Cells, Biomarkers Development, Voxel-based 3D Dosimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Apr 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.
Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.
In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.
The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.
The performance of different prostate cancer diagnostic methods is also in scope of the study.
Detailed description
Radioligand therapy (RLT) has emerged as an effective treatment of metastatic, castration resistant prostate cancer (mCRPC) for those patients having, prostate-specific membrane antigen (PSMA)-positive disease. This led to the FDA approval of 177Lu-PSMA-617 (PluvictoTM), a PSMA ligand radiolabelled with the β--particle emitter lutetium-177(177Lu). Despite the success of this treatment modality, the therapeutic response after RLT with 177Lu-based PSMA radioligands is limited and disease relapse inevitable. In addition, approximately 1/3 of the patients does not respond to 177Lu-based RLT despite PSMA-positive mCRPC.
It has been hypothesized that the insufficient absorbed dose delivery to macroscopic tumours and, in particular, to microscopic metastases with currently used 177Lu-based PSMA radioligands is the reason for the treatment failure in these patients. SibuDAB, a novel long-circulating PSMA ligand, was successfully tested in the preclinical setting in combination with terbium-161 (161Tb) that emits not only β--particles but also conversion and Auger electrons and, hence, delivers 2-4 times higher absorbed doses to microscopic tumours than 177Lu.
The researchers, therefore, propose to enhance the efficacy of PSMA-targeting RLT by using the long-circulating ligand (SibuDAB) labelled with 161Tb. The researchers expect 161Tb-SibuDAB to exhibit increased and/or prolonged tumour uptake with a higher deposition of energy (due to short ranged Auger electrons) resulting in a high linear energy transfer (LET) and, hence, relative biological effectiveness. 161Tb-SibuDAB should not only deliver the absorbed dose to the cellular nucleus (via β-- radiation) but also to the cell membrane and organelles (through the emission of conversion and Auger electrons) which, in mathematical models, leads to a 3-4-fold increased absorbed dose to single cancer cells compared to standard RLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In Phase Ia: Radiation dosimetry driven, head-to-head in cross-over design comparison of tumour and critical organ absorbed doses after sequential non-therapeutic injections of 161Tb-SibuDAB and 177Lu-PSMA-I\&T in the same mCRPC patients undergoing standard 177Lu-PSMA-I\&T RLT. In Phase Ib: Clinical and radiation dosimetry-based dose escalation study, with a classical 3+3 design, to identify the optimal biologic dose (injected activity) of 161Tb-SibuDAB for safe and effective RLT.
| Arm | Type | Receives |
|---|---|---|
| Cross-Over Group A | Active comparator | Drug: Injection, 161Tb-SibuDAB,1GBq, Drug: Injection, 177Lu-PSMA-I&T, 1GBqCross-over design (n=10, random allocation at a 1:1 ratio). Event order: 1. Injection of 1 GBq of 161Tb-SibuDAB, 2. 3 weeks washout period, 3. Injection of 1GBq of 177Lu-PSMA-I\&T |
| Cross-Over Group B | Active comparator | Drug: Injection, 161Tb-SibuDAB,1GBq, Drug: Injection, 177Lu-PSMA-I&T, 1GBqCross-over design (n=10, random allocation at a 1:1 ratio). Event order: 1. Injection of 1 GBq of 177Lu-PSMA-I\&T, 2. 3 weeks washout period, 3. Injection of 1GBq of 161Tb-SibuDAB |
| Dose Escalation Study | Experimental | Drug: Injection, 161Tb-SibuDAB, Dose EscalationArm composed of 5 patient cohorts each with 3-patients. Treatment consists of 4 cycles of 161Tb-SibuDAB based on the available MTD and DLT findings. Safety and efficacy evaluation performed after each therapy cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Consent form signed
- Male patients with age > 18 years
- Clinical indication for RLT with 177Lu-PSMA-I\&T (progressive PSMA-positive mCRPC patients after androgen receptor signalling pathway inhibitor and taxan-based chemotherapy or patient unfit for chemotherapy)
- Patients will be included in Phase Ia while being under active therapy with 177Lu-PSMA-I\&T (SoC) and after they have completed the first two cycles of 177Lu-PSMA-I\&T RLT
- At least 3 measurable tumours on PSMA PET/CT (>1.5 cm) with sufficiently intense PSMA uptake (SUVmax>20)
Key exclusion criteria (10 listed)
- Prior PSMA-targeted RLT (except for the 2 first cycles in Part Ia)
- PSMA-negative (or PSMA-negative / FDG-positive) disease
- Known intolerance against DOTA, DOTAGA, urea-based analogues or against any of the components/formulation of 177Lu-PSMA-I\&T or 161Tb-SibuDAB solutions.
- Ongoing infection at the screening visit or a serious infection in the past 4 weeks
- Administration of another investigational product in the last 60 days before Visit 1 Day 1
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 |
|---|---|---|
| Injection, 161Tb-SibuDAB,1GBqIntravenous injection via peripheral venous catheter of ~1GBq 161Tb-SibuDAB (~200 μg / ~125 nM) in saline | Drug | Cross-Over Group A, Cross-Over Group B |
| Injection, 177Lu-PSMA-I&T, 1GBqIntravenous injection via peripheral venous catheter of ~1GBq 161Tb-SibuDAB (~100 μg / ~65 nM) in saline | Drug | Cross-Over Group A, Cross-Over Group B |
| Injection, 161Tb-SibuDAB, Dose EscalationIntravenous injection via peripheral venous catheter of 161Tb-SibuDAB in saline. The intervention comprises 4 cycles at 6-week intervals. The 161Tb-SibuDAB entry activity will be calculated based on dosimetry and toxicity data from the first 3 patients in Phase Ia of the study. The escalated or de-escalated 161Tb-SibuDAB activity for the subsequent 3-patient cohorts will be determined based on the clinical and biochemical safety information and on organ dosimetry results of the entry/previous cohort. Up to 4 escalation or de-escalation steps will be performed. | Drug | Dose Escalation Study |
Primary outcome
Phase Ia: Tumour absorbed dose
Time frame: 3, 24, 48 and 168 hours after each injection
Comparison of median tumour absorbed dose, in Gy, after sequential injections of non-therapeutic test activity of 161Tb-SibuDAB and 177Lu-PSMA I\&T in the same patients. Tumour absorbed dose is obtained by SPECT/CT of head, thorax, abdomen and pelvis and represents the time integrated tumour activity (3 tumours per patient). To avoid carry-over effects, a period of at least 21 days will be allowed between the two consecutive test injections.
Phase Ib: Identification of the optimal biological dose of 161Tb-SibuDAB for mCRPC RLT
Time frame: baseline and 1 week, 2 weeks and 4 weeks after each injection. Long term: 6 and 12 months after RLT
Identification of the optimal biological dose of 161Tb-SibuDAB, in GBq, for mCRPC RLT. The optimal maximum tolerated dose / biological dose will be the highest 161Tb-SibuDAB injected activity which elicits a clinically relevant adverse event grade G3 (according to CTCAE 5.0, ranging from G1 to G5 where G1 corresponds to mild AE and and G5 corresponds to AE related death) in maximal 1 patient per cohort / 1 patient in two cohorts.
4 secondary outcomes
Phase Ia: Estimation of critical organ median absorbed doses
Time frame: 3, 24, 48 and 168 hours after each injection
Phase Ia: Estimation of the median tumour-to-critical organ absorbed dose ratios
Time frame: 3, 24, 48 and 168 hours after each injection
Phase Ib: Cumulative median tumour and organ absorbed doses after 4 cycles of 161Tb-SibuDAB RLT
Time frame: 3, 24, 48 and 168 hours after each injection
Phase Ib: Estimation of the "therapy index" for 161Tb-SibuDAB RLT.
Time frame: 3, 24, 48 and 168 hours after each injection
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 14 Aug 2024.
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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.
Alin Chirindel, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injection, 161Tb-SibuDAB,1GBq, Injection, 177Lu-PSMA-I&T, 1GBq and Injection, 161Tb-SibuDAB, Dose Escalation in people with Castration-resistant Prostate Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 12 inclusion and 10 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 14 Aug 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 Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Damian Wild, MD (+41 61 328 66 83, damian.wild@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Tumour absorbed dose (time frame: 3, 24, 48 and 168 hours after each injection). 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 14 Aug 2024.