Locally Recurrent Prostate CancerPhase 2NCT00686088
An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
A Phase 2 study testing PRX302 in people with Locally Recurrent Prostate Cancer, run by Sophiris Bio Corp at 2 sites in United States.
Trial summary
The purpose of this study is to determine the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA velocity, PSA doubling time and tumor burden following treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Locally Recurrent Prostate Cancer
- What is being tested?
- PRX302
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Sep 2009
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed a full course of radiation therapy for prostate cancer at least 2 years before enrollment.
- Biochemical failure at screening as determined by either the ASTRO or the Phoenix definitions.
- At least 5 available PSA readings after completion of radiation therapy and prior to screening.
- PSA level of not greater than 10 ng/mL.
- PSA doubling time of at least 9 months at screening.
- Biopsy-proven recurrent localized prostate cancer.
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- Tumor stage T1C to T2C.
- Prostate volume estimated at 40 mL or less as determined by TRUS.
- ECOG performance score 0 to 2.
- Serum testosterone of at least 1 ng/dL.
Who cannot join
- Prior history of metastatic prostate cancer.
- Salvage external beam therapy and/or salvage brachytherapy prior to enrollment.
- Biological, immunological, chemotherapeutic treatment or cryotherapy after completing radiation.
- Androgen ablation therapy within 12 months prior to enrollment.
- Recurrence of prostate cancer within 18 months of definitive primary radiotherapy.
- Other medication for prostate cancer.
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- Presence of active malignancy other than prostate cancer.
- Treatment with other investigational therapies within 12 months prior to enrolment.
- Presence of a chronic indwelling Foley catheter for obstructive uropathy.
- Previous transurethral resection of the prostate (TURP), transurethral resection of the bladder neck, photo-selective vaporization of the prostate (PVP) or other resection surgery in the urinary tract.
- Previous treatment with PRX302.
- Any evidence of metastatic disease on bone scan, CT or magnetic resonance imaging (MRI) within 3 months prior to enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Urology San Antonio
San Antonio, Texas, 78229
Scott & White Memorial Hospital
Temple, Texas, 76508
About this study
The purpose of this study is to determine the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA velocity, PSA doubling time and tumor burden following treatment.
- Conditions
- Locally Recurrent Prostate Cancer
- Being tested
- PRX302
- Keywords
- prostate cancer, locally recurrent, PRX302
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX302Drug
Determination of the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate.
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.
Measured: Day 45 and Day 180
Secondary outcomes (1)
Safety and tolerability of PRX302.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophiris Bio Corp
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686088
- Sponsor's protocol ID
- PRX302-1-02
- Status last verified
- Sep 2009
- First submitted
- 26 May 2008
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
- ClinicalTrials.gov ID
- NCT00686088
- Acronym / sponsor ID
- PRX302-1-02
- Conditions
- Locally Recurrent Prostate Cancer
- Keywords
- prostate cancer, locally recurrent, PRX302
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sophiris Bio CorpIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 May 2008 (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.
The purpose of this study is to determine the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA velocity, PSA doubling time and tumor burden following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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)
- Completed a full course of radiation therapy for prostate cancer at least 2 years before enrollment.
- Biochemical failure at screening as determined by either the ASTRO or the Phoenix definitions.
- At least 5 available PSA readings after completion of radiation therapy and prior to screening.
- PSA level of not greater than 10 ng/mL.
- PSA doubling time of at least 9 months at screening.
Key exclusion criteria (12 listed)
- Prior history of metastatic prostate cancer.
- Salvage external beam therapy and/or salvage brachytherapy prior to enrollment.
- Biological, immunological, chemotherapeutic treatment or cryotherapy after completing radiation.
- Androgen ablation therapy within 12 months prior to enrollment.
- Recurrence of prostate cancer within 18 months of definitive primary radiotherapy.
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 |
|---|---|---|
| PRX302Determination of the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate. | Drug | – |
Primary outcome
PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.
Time frame: Day 45 and Day 180
1 secondary outcome
Safety and tolerability of PRX302.
Time frame: 12 months.
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 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRX302 in people with Locally Recurrent Prostate Cancer, run by Sophiris Bio Corp at 2 sites 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 12 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 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening. (time frame: Day 45 and Day 180). 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 2009.