Prostate CancerPhase 2NCT05705700
Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)
A Phase 2 study testing Dutasteride and Abiraterone in people with Prostate Cancer, run by Masonic Cancer Center, University of Minnesota.
Trial summary
This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dutasteride and Abiraterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jan 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histological or cytological evidence of adenocarcinoma of the prostate
- Undergone orchiectomy, or have been on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
- Currently receiving abiraterone (ZYTIGA or FDA approved generic) in the castration sensitive (CSPC) or castration resistant (CRPC) setting with PSA progression in the absence of visceral, bone or lymph node progression. PSA progression is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases at least 2 weeks apart (based on Prostate Cancer Working Group Criteria, version 3 (PCWG3).
- Minimum PSA must be ≥1.0 ng/dL.
- Age 18 years of age or older.
- ECOG performance status 0 or 1.
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- Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment:
- absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- platelets ≥ 100 × 10^9/L
- hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
- total bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
- serum albumin ≥ 30 g/L (3.0 g/dL)
- Serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula
- Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the dutasteride treatment period and for 6 months after last dose or 3 weeks after the last dose of abiraterone whichever is longer. Persons are considered to be of childbearing potential unless one or the following applies:
- Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
- Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy.
- Voluntary written consent prior to the performance of any research related activit
Who cannot join
- Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to 5 alpha-reductase inhibitors (i.e. finasteride).
- Prior use of Enzalutamide, Apalutamide, or Darolutamide for the treatment of prostate cancer.
About this study
Official title: Biomarker Study Targeting Abiraterone Metabolites and Polymporphisms in Men With PSA Progression on Abiraterone for the Treatment of Castration Resistant or Castration Sensitive Prostate Cancer (The Bio-STAMP Study)
This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy.
- Conditions
- Prostate Cancer
- Being tested
- Dutasteride, Abiraterone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Also called Abiraterone
High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression
AbirateroneDrug
Also called Dutasteride
1000 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| 1245c positive (1245c+) patients with dutasteride | Experimental | Continue on abiraterone 1000 mg PO daily with dutasteride 3.5 mg PO daily as an add-on therapy until radiographic progression is documented Receives: Drug: Dutasteride; Drug: Abiraterone |
| 1245c positive (1245c+) patients | Experimental | Continue on abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented Receives: Drug: Abiraterone |
| 1245c negative (1245c-) patients | Experimental | abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented Receives: Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with radiographic progression free survival (rPFS) rate
Count the the number of patients with radiographic progression free survival (rPFS)
Measured: 24 Weeks after study treatment
Secondary outcomes (2)
Determine overall survival (OS)
The Kaplan-Meier product-limit estimator will be used to estimate OS distribution
Measured: 24 months from start of treatment assignment
Number of patients with a PSA decline of ≥ 50%
Count the number of patients with serologic progression. It is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases confirmed at least 2 weeks apart.
Measured: 24 weeks of adding of adding high-dose dutasteride
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Why it stopped: Feasibility
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 Masonic Cancer Center, University of MinnesotaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Ryan, MD, Principal investigator, Masonic Cancer Center, Univeristy of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705700
- Sponsor's protocol ID
- 2019LS229
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 27 Feb 2023
- Results posted
- 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Study Targeting Abiraterone Metabolites and Polymporphisms in Men With PSA Progression on Abiraterone for the Treatment of Castration Resistant or Castration Sensitive Prostate Cancer (The Bio-STAMP Study)
- ClinicalTrials.gov ID
- NCT05705700
- Acronym / sponsor ID
- 2019LS229
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 31 Jan 2023 (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.
This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1245c positive (1245c+) patients with dutasteride | Experimental | Drug: Dutasteride, Drug: AbirateroneContinue on abiraterone 1000 mg PO daily with dutasteride 3.5 mg PO daily as an add-on therapy until radiographic progression is documented |
| 1245c positive (1245c+) patients | Experimental | Drug: AbirateroneContinue on abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented |
| 1245c negative (1245c-) patients | Experimental | Drug: Abirateroneabiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histological or cytological evidence of adenocarcinoma of the prostate
- Undergone orchiectomy, or have been on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
- Currently receiving abiraterone (ZYTIGA or FDA approved generic) in the castration sensitive (CSPC) or castration resistant (CRPC) setting with PSA progression in the absence of visceral, bone or lymph node progression. PSA progression is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases at least 2 weeks apart (based on Prostate Cancer Working Group Criteria, version 3 (PCWG3).
- Minimum PSA must be ≥1.0 ng/dL.
- Age 18 years of age or older.
Key exclusion criteria (2 listed)
- Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to 5 alpha-reductase inhibitors (i.e. finasteride).
- Prior use of Enzalutamide, Apalutamide, or Darolutamide for the treatment of prostate cancer.
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 |
|---|---|---|
| DutasterideAlso: AbirateroneHigh dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression | Drug | 1245c positive (1245c+) patients with dutasteride |
| AbirateroneAlso: Dutasteride1000 mg PO daily | Drug | 1245c negative (1245c-) patients, 1245c positive (1245c+) patients, 1245c positive (1245c+) patients with dutasteride |
Primary outcome
Number of patients with radiographic progression free survival (rPFS) rate
Time frame: 24 Weeks after study treatment
Count the the number of patients with radiographic progression free survival (rPFS)
2 secondary outcomes
Determine overall survival (OS)
Time frame: 24 months from start of treatment assignment
Number of patients with a PSA decline of ≥ 50%
Time frame: 24 weeks of adding of adding high-dose dutasteride
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- 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. This study is not recruiting at the moment.
Charles Ryan, MD principal investigator
Masonic Cancer Center, Univeristy of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dutasteride and Abiraterone in people with Prostate Cancer, run by Masonic Cancer Center, University of Minnesota.
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 18 inclusion and 2 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: withdrawn, as of the sponsor's last update on 27 Feb 2023. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with radiographic progression free survival (rPFS) rate (time frame: 24 Weeks after study treatment). 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 27 Feb 2023.