Prostate CancerPhase 1NCT00379561
PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer
A Phase 1 study testing PSA-Activated PSA-PAH1 in people with Prostate Cancer, run by Sophiris Bio Corp at 1 site in United States.
Trial summary
This Phase 1 trial will evaluate the safety and tolerability of PSA-Activated PSA-PAH1 in subjects who have shown biochemical failure and have either completed at least one primary radiation therapy for prostate cancer and have evidence of recurrent local prostate cancer without metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSA-Activated PSA-PAH1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jul 2008
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Histologically proven prostate adenocarcinoma
- Completed a full course of definitive external beam radiation or definitive brachytherapy (but not both) as primary therapy for diagnosed prostate cancer at least one year prior to enrollment
- Subject must have at least one available PSA measurement that was taken 60 days or more following their primary therapy, but no later than 2 months prior to their screening visit (this measurement will serve as the first time point for computing a screening value for PSA doubling time)
- Subject's PSA doubling time at screening must be > 3 months (this doubling time will be computed by comparing the earliest available PSA that is 60 days or more following the subject's primary therapy but no later than 2 months prior to their screening visit, to the PSA measurement obtained during the screening visit)
- Within one year prior to enrollment:
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- Demonstrated "biochemical failure," as determined by three consecutive increases in PSA at least 2 weeks apart
- Multiple-site biopsy-confirmed local recurrence of prostate cancer
- Within 3 months prior to enrollment:
- No evidence of metastatic disease including no bone metastases on bone scan, or any lymph node, lung, liver or soft tissue metastases on a CT or MRI scan or any other evidence of metastatic disease
- No receipt of androgen ablation therapy [Note: Subjects may have received androgen ablation therapy in the past, but not within 3 months prior to enrollment. No subject will be removed from androgen ablation therapy prior to this trial to permit/facilitate eligibility for this trial.]
- Within 30 days prior to enrollment:
- Prostate gland weighing less than 40 g estimated on the basis of CT/ultrasound data
- Serum testosterone above castrate range (> 1 ng/dL)
- PSA level less than 20 ng/mL
- Eastern Cooperative Oncology Group (ECOG) score of 0-2
- Written informed consent
- Adequate organ function as evidenced by:
Who cannot join
- Any history of active malignancy other than prostate cancer
- Have active viral, bacterial or fungal infections that require systemic therapy
- Prior biological, immunological or chemotherapy for prostate cancer
- Receiving concurrent medication for prostate cancer
- Received as primary therapy for prostate cancer, definitive external beam radiation and concomitant brachytherapy
- Prior history of metastatic prostate cancer
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- Treatment with other investigational therapies within 12 months prior to enrollment that could produce a compromised immune system, or receipt of immunosuppressive drugs including corticosteroids or ketoconazole within 1 month prior to enrollment, or a history of immunodeficiency disease
- Recurrence of prostate cancer within 6 months after initiation of primary radiotherapy
- Active heart, liver, lung, renal disease, active infection or other serious uncontrolled illnesses
- Positive antibody test during screening for HIV-1, HIV-2, HTLV-1, HTLV-2, Hep B, or Hep C
- Unable or unwilling to return for required visits and follow-up examinations
- Have a chronic indwelling Foley catheter for obstructive uropathy
- Received salvage external beam radiotherapy and/or salvage seed brachytherapy prior to enrollment
- Received prior treatment with PSA-PAH1 (subjects may not be redosed under this protocol)
- Men unwilling to use condoms for the duration of the study (3 months) to prevent a pregnancy, and to avoid semen contact with their partner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Research Institute of Scott and White
Temple, Texas, 76502
About this study
Official title: A Phase 1 Trial of PSA-Activated PSA-PAH1 Therapy for Locally Recurrent Prostate Cancer Without Metastases After Primary Radiation Therapy
This Phase 1 trial will evaluate the safety and tolerability of PSA-Activated PSA-PAH1 in subjects who have shown biochemical failure and have either completed at least one primary radiation therapy for prostate cancer and have evidence of recurrent local prostate cancer without metastases.
Read the detailed description
For more information please contact Primary Investigator or Protox Therapeutics, Inc.
- Conditions
- Prostate Cancer
- Being tested
- PSA-Activated PSA-PAH1
- Keywords
- Prostate Cancer, Recurrent Prostate Cancer, Non-Metastatic prostate cancer, Recurrent Localized Prostate Cancer with Biochemical Failure
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA-Activated PSA-PAH1Drug
Also called PRX302, Topsalysin
| Study group | Role | What they receive |
|---|---|---|
| Intervention PSA-PAH1 | Experimental | Determination of the therapeutic activity of different concentrations of PSA-PAH1 at increasing doses of per gram of prostate. Receives: Drug: PSA-Activated PSA-PAH1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerance of PSA-PAH1
MTD of PSA-PAH1
Secondary outcomes (3)
Pharmacokinetic data on PSA-PAH1
Immune response to PSA-PAH1
Evidence of activity of PSA-PAH1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2007
- Study completionJul 2008
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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophiris Bio Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- King S Coffield, M.D., Principal investigator, Cancer Research Institute of Scott and White
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379561
- Sponsor's protocol ID
- PRX302
- Status last verified
- Oct 2018
- First submitted
- 20 Sep 2006
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of PSA-Activated PSA-PAH1 Therapy for Locally Recurrent Prostate Cancer Without Metastases After Primary Radiation Therapy
- ClinicalTrials.gov ID
- NCT00379561
- Acronym / sponsor ID
- PRX302
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Recurrent Prostate Cancer, Non-Metastatic prostate cancer, Recurrent Localized Prostate Cancer with Biochemical Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sophiris Bio CorpIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Sep 2006 (estimated)
- 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 Phase 1 trial will evaluate the safety and tolerability of PSA-Activated PSA-PAH1 in subjects who have shown biochemical failure and have either completed at least one primary radiation therapy for prostate cancer and have evidence of recurrent local prostate cancer without metastases.
Detailed description
For more information please contact Primary Investigator or Protox Therapeutics, Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention PSA-PAH1 | Experimental | Drug: PSA-Activated PSA-PAH1Determination of the therapeutic activity of different concentrations of PSA-PAH1 at increasing doses of per gram of prostate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 years of age or older
- Histologically proven prostate adenocarcinoma
- Completed a full course of definitive external beam radiation or definitive brachytherapy (but not both) as primary therapy for diagnosed prostate cancer at least one year prior to enrollment
- Subject must have at least one available PSA measurement that was taken 60 days or more following their primary therapy, but no later than 2 months prior to their screening visit (this measurement will serve as the first time point for computing a screening value for PSA doubling time)
- Subject's PSA doubling time at screening must be > 3 months (this doubling time will be computed by comparing the earliest available PSA that is 60 days or more following the subject's primary therapy but no later than 2 months prior to their screening visit, to the PSA measurement obtained during the screening visit)
Key exclusion criteria (15 listed)
- Any history of active malignancy other than prostate cancer
- Have active viral, bacterial or fungal infections that require systemic therapy
- Prior biological, immunological or chemotherapy for prostate cancer
- Receiving concurrent medication for prostate cancer
- Received as primary therapy for prostate cancer, definitive external beam radiation and concomitant brachytherapy
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 |
|---|---|---|
| PSA-Activated PSA-PAH1Also: PRX302, Topsalysin | Drug | Intervention PSA-PAH1 |
Primary outcome
Safety and Tolerance of PSA-PAH1
MTD of PSA-PAH1
3 secondary outcomes
Pharmacokinetic data on PSA-PAH1
Immune response to PSA-PAH1
Evidence of activity of PSA-PAH1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- PRX302Link provided by the sponsor.
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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.
King S Coffield, M.D. principal investigator
Cancer Research Institute of Scott and White
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 PSA-Activated PSA-PAH1 in people with Prostate Cancer, run by Sophiris Bio Corp 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 18 inclusion and 15 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 29 Oct 2018. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and Tolerance of PSA-PAH1. 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 29 Oct 2018.