Prostatic NeoplasmsPhase 2NCT03572387
A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
A Phase 2 study testing 5-Azacitidine, all trans retinoic acid and Lupron in people with Prostatic Neoplasms and Prostate Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a prospective, open-label, randomized, cross-over, pilot study of reprogramming therapy in patients with recurrent PCa based on rising PSA only. The primary objectives are to compare the disease progression-free rate at the end of 12 weeks of treatment between 5-AZA+ATRA and no therapy and to assess safety of… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Neoplasms, Prostate Cancer
- What is being tested?
- 5-Azacitidine, all trans retinoic acid and Lupron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 8 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Rising PSA
- PSADT ≤ 10 months prior to initiation of ADT
- No evidence of regional or active distant metastases, except for regional metastasis where salvage radiation therapy is not an option
- Indication for ADT after receiving definitive local therapy
- Males ≥ 18 years.
Show all 10Show fewer
- ECOG performance status of ≤ 2
- Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy
- Ability to understand and the willingness to sign a written informed consent
- Ability to adhere to the study visit schedule and requirements of the protocol
Who cannot join
- Patients who have received ADT and/or other chemotherapy within 3 months prior to entering the study.
- Patients who have had radiotherapy or surgery within 4 weeks prior to entering the study. Minimally-invasive procedures for the purpose of diagnosis or staging of the disease are permitted.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-AZA and ATRA.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Show all 14Show fewer
- Significant active cardiac disease within the previous 6 months
- Inadequate organ and marrow function as defined below:
- leukocytes ≤ 3,000/mcL
- absolute neutrophil count ≤ 1,500/mcL
- platelets ≤ 100,000/mcl
- total bilirubin above normal institutional limits
- AST(SGOT)/ALT(SPGT) ≥ 2.5 X institutional upper limit of normal
- creatinine above normal institutional limits
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Pilot Study of the Combination of 5-azacitidine (5-AZA) and All-trans Retinoic Acid (ATRA) for Prostate Cancer (PCa) With PSA-only Recurrence After Definitive Local Treatment
This is a prospective, open-label, randomized, cross-over, pilot study of reprogramming therapy in patients with recurrent PCa based on rising PSA only. The primary objectives are to compare the disease progression-free rate at the end of 12 weeks of treatment between 5-AZA+ATRA and no therapy and to assess safety of the 5-AZA and ATRA combination. All study enrollees will receive Lupron. After one month, they will be assigned in a 1:1 randomization to either the '5-AZA+ATRA' group or the 'no therapy' group. Patients in the '5-AZA + ATRA' group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. In the 'no therapy' group, patients will initially be observed for 3 cycles and then receive treatment for 3 cycles, in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for up to 24 months from the start of the study or until the events leading to discontinuation are observed.
- Conditions
- Prostatic Neoplasms, Prostate Neoplasms, Prostate Cancer
- Being tested
- 5-Azacitidine, all trans retinoic acid, Lupron
- Keywords
- Prostate Neoplasms, Prostatic Neoplasms, 5-Azacitidine, all-trans retinoic acid, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-AzacitidineDrug
Also called 5-AZA
subcutaneously on days 1-5 at a dose of 40 mg/m^2
all trans retinoic acidDrug
Also called ATRA
45 mg/m^2, will be taken orally on days 3-7 of each cycle, divided into two doses
LupronDrug
Also called Leuprolide
7.5 mg x 1
| Study group | Role | What they receive |
|---|---|---|
| 5-AZA + ATRA ('early' 5-AZA+ATRA) | Experimental | Combination of 5-Azacitidine (5-AZA) + all trans retinoic acid (ATRA) group after one month of Lupron, group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. Receives: Drug: 5-Azacitidine; Drug: all trans retinoic acid; Drug: Lupron |
| No therapy ('delayed' 5-AZA+ATRA) | Active comparator | After one month of lupron, patients will receive no therapy for 3 cycles (12 weeks). After this observation period, patients will receive combination of 5-Azacitidine (5-AZA) + all trans retinoic acid (ATRA) group on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. Receives: Drug: 5-Azacitidine; Drug: all trans retinoic acid; Drug: Lupron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With PSA Response
Number of participants with PSA response, as defined by PSA decreased > 30% as compared from baseline.
Measured: baseline and 24 weeks
Secondary outcomes (1)
Percentage of Patients With Prolongation of PSA Doubling Time (PSADT) Post-treatment
Percentage of patients with prolongation of PSA doubling time (PSADT) post-treatment compared to baseline after treatment with 3 cycles of Aza and ATRA.
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start20 Aug 2018
- Primary completion19 Jun 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Model description
- ll study enrollees will receive Lupron. After one month, they will be assigned in a 1:1 randomization to either the '5-AZA+ATRA' group or the 'delay therapy' group. Patients in the '5-AZA + ATRA' group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. In the 'no therapy' group, patients will initially be observed for 3 cycles and then receive treatment for 3 cycles, in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for up to 24 months from the start of the study or until the events leading to discontinuation are observed.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaibhav G Patel, Icahn School of Medicine at Mount Sinai
- Investigators
- Vaibhav G Patel, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572387
- Sponsor's protocol ID
- GCO 16-0752
- Status last verified
- Apr 2024
- First submitted
- 18 Jun 2018
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected during the course of this clinical trial will primarily be shared with other investigators and health system staff, the IRB, FDA, and other reporting agencies, and/or transferred to other collaborators. Prior to transfer, the data collected must comply with, and must be limited by, the MSH's guidelines for Protecting the Rights and Privacy of Human Subjects.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Combination of 5-azacitidine (5-AZA) and All-trans Retinoic Acid (ATRA) for Prostate Cancer (PCa) With PSA-only Recurrence After Definitive Local Treatment
- ClinicalTrials.gov ID
- NCT03572387
- Acronym / sponsor ID
- GCO 16-0752
- Conditions
- Prostatic Neoplasms, Prostate Neoplasms, Prostate Cancer
- Keywords
- Prostate Neoplasms, Prostatic Neoplasms, 5-Azacitidine, all-trans retinoic acid, PSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 19 Jun 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 30 Apr 2024
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 prospective, open-label, randomized, cross-over, pilot study of reprogramming therapy in patients with recurrent PCa based on rising PSA only. The primary objectives are to compare the disease progression-free rate at the end of 12 weeks of treatment between 5-AZA+ATRA and no therapy and to assess safety of the 5-AZA and ATRA combination. All study enrollees will receive Lupron. After one month, they will be assigned in a 1:1 randomization to either the '5-AZA+ATRA' group or the 'no therapy' group. Patients in the '5-AZA + ATRA' group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. In the 'no therapy' group, patients will initially be observed for 3 cycles and then receive treatment for 3 cycles, in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for up to 24 months from the start of the study or until the events leading to discontinuation are observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ll study enrollees will receive Lupron. After one month, they will be assigned in a 1:1 randomization to either the '5-AZA+ATRA' group or the 'delay therapy' group. Patients in the '5-AZA + ATRA' group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. In the 'no therapy' group, patients will initially be observed for 3 cycles and then receive treatment for 3 cycles, in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for up to 24 months from the start of the study or until the events leading to discontinuation are observed.
| Arm | Type | Receives |
|---|---|---|
| 5-AZA + ATRA ('early' 5-AZA+ATRA) | Experimental | Drug: 5-Azacitidine, Drug: all trans retinoic acid, Drug: LupronCombination of 5-Azacitidine (5-AZA) + all trans retinoic acid (ATRA) group after one month of Lupron, group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. |
| No therapy ('delayed' 5-AZA+ATRA) | Active comparator | Drug: 5-Azacitidine, Drug: all trans retinoic acid, Drug: LupronAfter one month of lupron, patients will receive no therapy for 3 cycles (12 weeks). After this observation period, patients will receive combination of 5-Azacitidine (5-AZA) + all trans retinoic acid (ATRA) group on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Rising PSA
- PSADT ≤ 10 months prior to initiation of ADT
- No evidence of regional or active distant metastases, except for regional metastasis where salvage radiation therapy is not an option
- Indication for ADT after receiving definitive local therapy
Key exclusion criteria (14 listed)
- Patients who have received ADT and/or other chemotherapy within 3 months prior to entering the study.
- Patients who have had radiotherapy or surgery within 4 weeks prior to entering the study. Minimally-invasive procedures for the purpose of diagnosis or staging of the disease are permitted.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-AZA and ATRA.
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 |
|---|---|---|
| 5-AzacitidineAlso: 5-AZAsubcutaneously on days 1-5 at a dose of 40 mg/m^2 | Drug | 5-AZA + ATRA ('early' 5-AZA+ATRA), No therapy ('delayed' 5-AZA+ATRA) |
| all trans retinoic acidAlso: ATRA45 mg/m^2, will be taken orally on days 3-7 of each cycle, divided into two doses | Drug | 5-AZA + ATRA ('early' 5-AZA+ATRA), No therapy ('delayed' 5-AZA+ATRA) |
| LupronAlso: Leuprolide7.5 mg x 1 | Drug | 5-AZA + ATRA ('early' 5-AZA+ATRA), No therapy ('delayed' 5-AZA+ATRA) |
Primary outcome
Number of Participants With PSA Response
Time frame: baseline and 24 weeks
Number of participants with PSA response, as defined by PSA decreased > 30% as compared from baseline.
1 secondary outcome
Percentage of Patients With Prolongation of PSA Doubling Time (PSADT) Post-treatment
Time frame: baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data collected during the course of this clinical trial will primarily be shared with other investigators and health system staff, the IRB, FDA, and other reporting agencies, and/or transferred to other collaborators. Prior to transfer, the data collected must comply with, and must be limited by, the MSH's guidelines for Protecting the Rights and Privacy of Human Subjects.
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Vaibhav G Patel, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 5-Azacitidine, all trans retinoic acid and Lupron in people with Prostatic Neoplasms and Prostate Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 10 inclusion and 14 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: finished, as of the sponsor's last update on 30 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With PSA Response (time frame: baseline and 24 weeks). 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 30 Apr 2024.