Prostate CancerPhase 3PROTECTNCT00779402
PROvenge Treatment and Early Cancer Treatment
A Phase 3 study testing Sipuleucel-T in people with Prostate Cancer, run by Dendreon at 18 sites in United States.
Trial summary
The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sipuleucel-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2001to May 2015
- Phase
- Phase 3
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of adenocarcinoma of the prostate.
- Within at least 3 months, but not more than 10 years, prior to initiation of the run-in phase with LHRH-a depot, the subject has undergone a radical prostatectomy for Stage T1b - T3c, N0 - N1, Nx, or M0 disease Subjects who experienced their first PSA recurrence within 2 years post completion of initial therapy of curative intent was eligible without consideration of the Gleason score of the tumor specimen. Subjects who experienced their first PSA relapse between 2 and 10 years post completion of initial therapy of curative intent was eligible only if the Gleason score of the tumor specimen was ≥ 7.
- Therapeutic PSA response to primary therapy was below 0.4 ng/mL.
- Tumor specimen positive for PAP.
- PSA relapse while not currently receiving androgen ablation therapy.
- If androgen ablation was given for a previous PSA relapse, PSA must have increased to a level at least 25% above the nadir observed while on this therapy, and to an absolute level of at least 3 ng/mL.
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- Subjects who had been treated with adjuvant or salvage radiation following radical prostatectomy, or with either LHRH-a (e.g., leuprolide acetate or goserelin acetate) or non-steroidal anti-androgen therapy (e.g., bicalutamide 150 mg/day) for a prior PSA relapse, may enter the study provided: Post-prostatectomy PSA was never ≥ 20 ng/mL; PSA was not rising while subject received hormonal therapy, and; For any hormonal therapy received, the last effective day of androgen deprivation was at least 6 months prior to the date of LHRH-a depot placement.
- Confirmed Stage M0 disease.
- Estimated life expectancy of at least 1 year.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Ability to understand the trial procedures and requirements.
- ≥ 18 and ≤ 80 years of age.
- Ability to understand and willingness to sign an informed consent form.
Who cannot join
- Exclusion Criteria for Entry into the Run-In Phase (Week -13)
- Metastasis.
- Clinical evidence of local recurrence other than PSA elevation (e.g., palpable induration or mass in the prostatic fossa).
- Any surgery within 4 weeks prior to the date of LHRH-a depot placement.
- Prior orchiectomy.
- PSA ≥ 20 ng/mL at any time after radical prostatectomy.
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- Current systemic steroid therapy (inhaled or topical steroids are acceptable).
- Any chemotherapy within 4 months prior to the LHRH-a depot placement.
- Prior immunotherapy or therapy with other experimental agents for prostate cancer.
- Treatment with radioactive seeds within 12 months prior to the LHRH a depot placement.
- History of any other prior malignancy other than resected basal or squamous cell carcinoma of the skin within 5 years of entry.
- Concurrent participation in another clinical trial involving experimental medication.
- Any disease, condition, social, or geographical constraint that in the opinion of the Investigator or medical monitor reduced the probability that the subject will complete the trial or affects the evaluation of study end points
- Central laboratory value of PSA ≥ 1 ng/mL at the end of the LHRH-a run-in phase.
- Randomized more than 3 weeks following the last effective date of testicular androgen suppression (as described in the package insert).
- Any use of herbal preparations (e.g., Prostate Cancer (PC) -SPES or saw palmetto) within 4 weeks prior to randomization.
- Any contraindication to leukapheresis or infusion of sipuleucel-T or control.
- Positive serology for human immunodeficiency virus (HIV)-1 or 2, human lymphotropic virus (HTLV)-1 or 2, or evidence of active Hepatitis B or C infection.
- Any ongoing active bacterial, viral, or fungal infection.
- The use of any systemic therapy for prostate cancer following randomization and prior to BF (PSA ≥ 3 ng/mL).
- Placement of radioactive seeds or salvage radiation before BF (PSA ≥ 3 ng/mL) documented.
- Initiation of systemic corticosteroids at doses greater than the equivalent of 40 mg hydrocortisone per day (inhaled steroids are allowed) before BF.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045-3206
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Urology Health Specialists - Bryn Mawr
Bryn Mawr, Pennsylvania, 19010
McKay Urology
Charlotte, North Carolina, 28207
AKSM Clinical Research Group
Columbus, Ohio, 43214
South Orange County Medical Research
Laguna Hills, California, 92653
University of Tennessee
Memphis, Tennessee, 38163
Mount Sinai School of Medicine
New York, New York, 10029
Oncology Specialists, SC
Park Ridge, Illinois, 60068-1174
Albert Einstein Medical Building
Philadelphia, Pennsylvania, 19141
Providence Medical Center
Portland, Oregon, 97213
Oregon Health and Sciences University
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642-0001
Bryn Mawr Urology Group
Rosemont, Pennsylvania, 19010
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Medical Center
Seattle, Washington, 98104
Oregon Urology Institute
Springfield, Oregon, 97477
Urology of Virginia, PC
Virginia Beach, Virginia, 23462
About this study
Official title: Autologous PAP-loaded Dendritic Cell Vaccine (Sipuleucel-T, APC8015, Provenge®) in Patients With Non-metastatic Prostate Cancer Who Experience PSA Elevation Following Radical Prostatectomy: a Randomized, Controlled, Double-blind Trial
The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US. The purpose of the study was to determine if sipuleucel-T was effective for treatment of early stage, non-metastatic prostate cancer. The study compared the active vaccine to control to determine whether the product delayed the time until cancer progression.
Read the detailed description
This was a prospective, double blind, controlled, randomized trial of immunotherapy with prostatic acid phosphatase (PAP)-loaded autologous antigen presenting cells (APCs), in subjects with non metastatic prostate cancer. Subjects that qualified for this study were men who had previously undergone a prostatectomy and whose only sign of disease recurrence was a rise in serum prostate specific antigen (PSA).
The primary objectives were to compare the time to biochemical failure (BF, PSA greater than or equal to 3 ng/mL) between sipuleucel-T (treatment group) and control, and to study the safety of sipuleucel-T.
Following short-term open-label treatment with a luteinizing hormone-releasing hormone-analogue (LHRH-a), Subjects completed a checklist designed to compare androgen suppression-related side effects during periods with and without androgen suppression.
Subjects who achieved a PSA of < 1 ng/ml were randomized to blinded treatment assignments of either sipuleucel-T or control in a 2:1 ratio. Following randomization, subjects underwent 3 leukapheresis procedures on alternate weeks (Weeks 0, 2, and 4). Approximately three days following each leukapheresis procedure, subjects received an infusion of either sipuleucel-T or control.
At the time BF was confirmed, subjects were eligible for a booster infusion. The booster process consisted of 1 leukapheresis procedure followed by 1 infusion of sipuleucel-T. The booster process, in effect under protocol amendment 5, differed from the previous booster process that consisted of 1 infusion of the same treatment assigned at randomization (sipuleucel-T or control).
Subjects continued to be observed until DF was confirmed by bone scan or computed tomography (CT) scan, or other imaging modalities as clinically indicated. After confirmed DF, subjects were followed by telephone every 6 months for safety and survival, treatment-related AEs, any CVEs, or new therapies for prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Control, Sipuleucel-T
- Keywords
- cancer, prostate cancer, prostatectomy, PSA, sipuleucel-T, PROVENGE, APC8015, non-metastatic, nonmetastatic, androgen-sensitive, androgen sensitive, biochemical recurrence, biochemically recurrent, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells, cancer vaccine
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen.
Sipuleucel-TBiological
Also called Provenge®, APC8015
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
| Study group | Role | What they receive |
|---|---|---|
| Sipuleucel-T | Experimental | Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions. Receives: Biological: Sipuleucel-T |
| Control | Placebo comparator | Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Biochemical Failure Cumulative Incidence Percentile
Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL
Measured: Every 3 months post-infusion
Number of Subjects That Met Biochemical Failure Status
time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.
Measured: Every 3 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2001
- Primary completionAug 2006
- Study completionMay 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Israel, MD, Study director, Valeant Pharmaceuticals North America LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779402
- Sponsor's protocol ID
- P-11
- Acronym
- PROTECT
- Status last verified
- Jun 2017
- First submitted
- 22 Oct 2008
- Last updated
- 29 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beer TM, Schellhammer PF, Corman JM, Glode LM, Hall SJ, Whitmore JB, Frohlich MW, Penson DF. Quality of life after sipuleucel-T therapy: results from a randomized, double-blind study in patients with androgen-dependent prostate cancer. Urology. 2013 Aug;82(2):410-5. doi: 10.1016/j.urology.2013.04.049.
PubMed 23896100
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous PAP-loaded Dendritic Cell Vaccine (Sipuleucel-T, APC8015, Provenge®) in Patients With Non-metastatic Prostate Cancer Who Experience PSA Elevation Following Radical Prostatectomy: a Randomized, Controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT00779402
- Acronym / sponsor ID
- PROTECT / P-11
- Conditions
- Prostate Cancer
- Keywords
- cancer, prostate cancer, prostatectomy, PSA, sipuleucel-T, PROVENGE, APC8015, non-metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Aug 2006 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 29 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US. The purpose of the study was to determine if sipuleucel-T was effective for treatment of early stage, non-metastatic prostate cancer. The study compared the active vaccine to control to determine whether the product delayed the time until cancer progression.
Detailed description
This was a prospective, double blind, controlled, randomized trial of immunotherapy with prostatic acid phosphatase (PAP)-loaded autologous antigen presenting cells (APCs), in subjects with non metastatic prostate cancer. Subjects that qualified for this study were men who had previously undergone a prostatectomy and whose only sign of disease recurrence was a rise in serum prostate specific antigen (PSA).
The primary objectives were to compare the time to biochemical failure (BF, PSA greater than or equal to 3 ng/mL) between sipuleucel-T (treatment group) and control, and to study the safety of sipuleucel-T.
Following short-term open-label treatment with a luteinizing hormone-releasing hormone-analogue (LHRH-a), Subjects completed a checklist designed to compare androgen suppression-related side effects during periods with and without androgen suppression.
Subjects who achieved a PSA of < 1 ng/ml were randomized to blinded treatment assignments of either sipuleucel-T or control in a 2:1 ratio. Following randomization, subjects underwent 3 leukapheresis procedures on alternate weeks (Weeks 0, 2, and 4). Approximately three days following each leukapheresis procedure, subjects received an infusion of either sipuleucel-T or control.
At the time BF was confirmed, subjects were eligible for a booster infusion. The booster process consisted of 1 leukapheresis procedure followed by 1 infusion of sipuleucel-T. The booster process, in effect under protocol amendment 5, differed from the previous booster process that consisted of 1 infusion of the same treatment assigned at randomization (sipuleucel-T or control).
Subjects continued to be observed until DF was confirmed by bone scan or computed tomography (CT) scan, or other imaging modalities as clinically indicated. After confirmed DF, subjects were followed by telephone every 6 months for safety and survival, treatment-related AEs, any CVEs, or new therapies for prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sipuleucel-T | Experimental | Biological: Sipuleucel-TSubjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions. |
| Control | Placebo comparator | Other: ControlSubjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologic diagnosis of adenocarcinoma of the prostate.
- Within at least 3 months, but not more than 10 years, prior to initiation of the run-in phase with LHRH-a depot, the subject has undergone a radical prostatectomy for Stage T1b - T3c, N0 - N1, Nx, or M0 disease Subjects who experienced their first PSA recurrence within 2 years post completion of initial therapy of curative intent was eligible without consideration of the Gleason score of the tumor specimen. Subjects who experienced their first PSA relapse between 2 and 10 years post completion of initial therapy of curative intent was eligible only if the Gleason score of the tumor specimen was ≥ 7.
- Therapeutic PSA response to primary therapy was below 0.4 ng/mL.
- Tumor specimen positive for PAP.
- PSA relapse while not currently receiving androgen ablation therapy.
Key exclusion criteria (22 listed)
- Exclusion Criteria for Entry into the Run-In Phase (Week -13)
- Metastasis.
- Clinical evidence of local recurrence other than PSA elevation (e.g., palpable induration or mass in the prostatic fossa).
- Any surgery within 4 weeks prior to the date of LHRH-a depot placement.
- Prior orchiectomy.
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 |
|---|---|---|
| ControlAutologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen. | Other | Control |
| Sipuleucel-TAlso: Provenge®, APC8015Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). | Biological | Sipuleucel-T |
Primary outcome
Time to Biochemical Failure Cumulative Incidence Percentile
Time frame: Every 3 months post-infusion
Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL
Number of Subjects That Met Biochemical Failure Status
Time frame: Every 3 months post-infusion
time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23896100Beer TM, Schellhammer PF, Corman JM, Glode LM, Hall SJ, Whitmore JB, Frohlich MW, Penson DF. Quality of life after sipuleucel-T therapy: results from a randomized, double-blind study in patients with androgen-dependent prostate cancer. Urology. 2013 Aug;82(2):410-5. doi: 10.1016/j.urology.2013.04.049.
- Prostate Cancer Research InstituteLink provided by the sponsor.
- USTOO InternationalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Robert Israel, MD study director
Valeant Pharmaceuticals North America LLC
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sipuleucel-T in people with Prostate Cancer, run by Dendreon at 18 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 13 inclusion and 22 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 Jan 2018). 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?
Time to Biochemical Failure Cumulative Incidence Percentile (time frame: Every 3 months post-infusion). 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?
On the ClinicalTrials.gov record for NCT00779402, which also lists 1 linked publication.
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 Jan 2018.