Prostatic NeoplasmsPhase 1NCT01685489
A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
A Phase 1 study testing Docetaxel, PSK® in people with Prostatic Neoplasms, run by Bastyr University at 1 site in United States.
Trial summary
This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Docetaxel, PSK®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to not given
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients 18 years or older
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Evidence of metastatic disease by standard imaging studies (bone scan, Computerized Tomography Scan (CT) or Magnetic Resonance Imaging (MRI))
- Testosterone levels <50 ng/dL
- Confirmed progressive disease defined by one or more of the following:
- an increase in PSA, > 2ng/dL x 2 or more values at least 1 week apart in the setting of metastatic disease
Show all 24Show fewer
- appearance of new bone lesions on bone scan
- progression of soft tissue lesion defined by the Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 criteria
- Concurrent use of an agent for testosterone suppression (e.g., Luteinizing Hormone Releasing Hormone [LHRH] agonist) if the patient is not surgically castrate
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 determined within 28 days before enrollment
- Recovery to CTCAE grade ≤ 1 toxicity, to patient's baseline status (except alopecia), or toxicities deemed irreversible from the effects of prior cancer therapy (CTCAEs grade > 1 that are not considered a safety risk by the investigator will be allowed)
- Adequate bone marrow function defined as:
- absolute neutrophil count (ANC) > 1500 cells/mm³ without growth factor support
- platelet count > 100,000 cells/mm³ without transfusion or growth factor support
- hemoglobin > 9g/dL without transfusion or growth factor support
- Adequate liver function defined as:
- total bilirubin < upper limit of normal (ULN)
- alanine aminotransferase (ALT) < 1.5 x ULN
- aspartate aminotransferase (AST) < 1.5 x ULN
- Adequate renal function defined as serum creatinine level within normal limits (WNL)
- At least a 6-month or greater life expectancy
- Ability to understand and sign a written informed consent, which will be obtained from study participants before undergoing any study-specific procedures
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- Suitable venous access for the study-required blood sampling (i.e., including PK sampling)
Who cannot join
- Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic disease
- Prior adjuvant or neo-adjuvant chemotherapy within 12 months of study entry
- Last dose of sipuleucel-T therapy within 4 weeks of enrollment
- Any investigational therapies within 4 weeks of study entry
- Radiotherapy within 4 weeks of study entry
- Major surgery within 4 weeks of study entry, and not fully recovered to baseline or a stable clinical status
Show all 19Show fewer
- Uncontrolled high blood pressure (systolic blood pressure > 160mmHg, diastolic blood pressure > 95mmHg)
- Receiving chronic steroid therapy. Topical and inhaled steroids are permitted
- Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80, or to mushroom products
- Any comorbid condition or unresolved toxicity that would preclude administration of docetaxel
- Medical contraindication to any docetaxel pre-medications
- History of > grade 2 neurotoxicity or any toxicity from any cause that has not resolved to < grade 1
- Brain or other CNS metastasis
- The need for chronic daily immunosuppressive therapy, including concurrent use of prednisone
- Evidence of active second malignancy, except non-melanoma skin cancer
- Infection requiring intravenous antibiotic therapy or other severe infection within 14 days preceding first dose of study drug
- Inability to swallow oral medication or maintain a fast, as required 2 hours before and 1 hour after PSK administration
- Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction
- Other medical or psychiatric condition that may increase the risk associated with trial participation or any other condition in the judgment of the investigator that may interfere with the interpretation of trial results or would make the patient inappropriate for enrollment in this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4 (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of PSK/placebo lead-in and during cycles 1 and 4.
- Conditions
- Prostatic Neoplasms
- Being tested
- Docetaxel, PSK®, Docetaxel, Placebo
- Keywords
- Prostate, Neoplasm, Adenocarcinoma, Cancer, Metastatic, Castrate resistant, Docetaxel, PSK, Krestin, Trametes versicolor, Safety, Maximum tolerated dose, Mushroom, Natural, Immunotherapy
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Adenocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, PSK®Drug
Also called Polysaccharide-K, Krestin, Polysaccharide-Kureha
Docetaxel, PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel, PSK® | Experimental | A 21-day lead-in oral PSK alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 evey 3 weeks for three cycles. After the third dose of docetaxel, study drug will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered. Receives: Drug: Docetaxel, PSK® |
| Docetaxel, Placebo | Placebo comparator | A 21-day lead-in oral placebo alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. After the third dose of docetaxel, the placebo will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered. Receives: Drug: Docetaxel, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine tolerability dose of PSK alone and in combination with docetaxel
Adverse events are graded to determine a dose limiting toxicity of PSK during the lead-in PSK alone and during the docetaxel treatment in combination with PSK.
Measured: 42 days
Determine maximum tolerated dose and recommended phase 2 dose of PSK in combination with docetaxel
When the maximum tolerated dose is determined, a total of 15 patients will be treated with the recommended phase 2 dose with the combination of docetaxel chemotherapy.
Measured: 106 days
Secondary outcomes (5)
Pharmacokinetics of docetaxel when combined with oral PSK
The plasma docetaxel levels are analyzed at eight time points during the cycle 1 of standard intravenous docetaxel at 75 mg/m2 with oral PSK/Placebo. After the seven-day washout of PSK/placebo at the cycle 3, the plasma docetaxel levels are analyzed again at eight time points during the cycle 4 of docetaxel treatment without PSK/Placebo.
Measured: 106 days
Pharmacokinetics of oral PSK dosing and in combination with docetaxel
The serum PSK levels are analyzed at two time points during the lead-in cycle and eight time points during the cycle 1 of standard intravenous docetaxel at 75 mg/m2 with oral PSK/Placebo. After the seven-day washout of PSK/placebo at the cycle 3, the plasma docetaxel levels are analyzed again at eight time points during the cycle 4 of docetaxel treatment without PSK/Placebo.
Measured: 106 days
Immunological laboratory analysis
Natural Killer (NK) cell functional activity, distributions of NK, B, and T cells, and IFN-gamma and TNF-alpha production capacity are analyzed and compared to those of the placebo group.
Measured: 106 days
Clinical tumor markers
Circulating tumor cell (CTC) and prostate specific antigen (PSA) levels are compared to that of the placebo group during the oral PSK lead-in period and during the combination therapy with docetaxel and PSK.
Measured: 106 days
Prostatic acid phosphatase
The serum level of prostatic acid phosphatase levels are compared to that of the placebo group during the oral PSK lead-in period and during the combination therapy with docetaxel and PSK.
Measured: 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startMay 2013
Why it stopped: funding sequestered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Fred Hutchinson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Celestia Higano, MD, Study director, Seattle Cancer Care Alliance - University of WashingtonCynthia A Wenner, Ph.D, Study director, Bastyr UniversityLeanna J Standish, PhD, ND, LAc, Principal investigator, Bastyr UniversityMary (Nora) L Disis, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685489
- Sponsor's protocol ID
- 1U19AT006028-01A1
- Status last verified
- Oct 2015
- First submitted
- 6 Sep 2012
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Antonarakis ES, Drake CG. Current status of immunological therapies for prostate cancer. Curr Opin Urol. 2010 May;20(3):241-6. doi: 10.1097/MOU.0b013e3283381793.
PubMed 20179598de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008 Oct 1;14(19):6302-9. doi: 10.1158/1078-0432.CCR-08-0872.
PubMed 18829513Fisher M, Yang LX. Anticancer effects and mechanisms of polysaccharide-K (PSK): implications of cancer immunotherapy. Anticancer Res. 2002 May-Jun;22(3):1737-54.
PubMed 12168863Fizazi K, Sternberg CN, Fitzpatrick JM, Watson RW, Tabesh M. Role of targeted therapy in the treatment of advanced prostate cancer. BJU Int. 2010 Mar;105(6):748-67. doi: 10.1111/j.1464-410X.2010.09236.x.
PubMed 20353536Fujita H, Ogawa K, Ikuzawa M, Muto S, Matsuki M, Nakajima S, Shimamura M, Togawa M, Yoshikumi C, Kawai Y. Effect of PSK, a protein-bound polysaccharide from Coriolus versicolor, on drug-metabolizing enzymes in sarcoma-180 bearing and normal mice. Int J Immunopharmacol. 1988;10(4):445-50. doi: 10.1016/0192-0561(88)90132-4.
PubMed 3139576Hurria A, Fleming MT, Baker SD, Kelly WK, Cutchall K, Panageas K, Caravelli J, Yeung H, Kris MG, Gomez J, Miller VA, D'Andrea G, Scher HI, Norton L, Hudis C. Pharmacokinetics and toxicity of weekly docetaxel in older patients. Clin Cancer Res. 2006 Oct 15;12(20 Pt 1):6100-5. doi: 10.1158/1078-0432.CCR-06-0200.
PubMed 17062686Iino Y, Yokoe T, Maemura M, Horiguchi J, Takei H, Ohwada S, Morishita Y. Immunochemotherapies versus chemotherapy as adjuvant treatment after curative resection of operable breast cancer. Anticancer Res. 1995 Nov-Dec;15(6B):2907-11.
PubMed 8669887Ikuzawa M, Matsunaga K, Nishiyama S, Nakajima S, Kobayashi Y, Andoh T, Kobayashi A, Ohhara M, Ohmura Y, Wada T, et al. Fate and distribution of an antitumor protein-bound polysaccharide PSK (Krestin). Int J Immunopharmacol. 1988;10(4):415-23. doi: 10.1016/0192-0561(88)90128-2.
PubMed 3170055Lu H, Yang Y, Gad E, Inatsuka C, Wenner CA, Disis ML, Standish LJ. TLR2 agonist PSK activates human NK cells and enhances the antitumor effect of HER2-targeted monoclonal antibody therapy. Clin Cancer Res. 2011 Nov 1;17(21):6742-53. doi: 10.1158/1078-0432.CCR-11-1142. Epub 2011 Sep 14.
PubMed 21918170Makkouk A, Abdelnoor AM. The potential use of Toll-like receptor (TLR) agonists and antagonists as prophylactic and/or therapeutic agents. Immunopharmacol Immunotoxicol. 2009;31(3):331-8. doi: 10.1080/08923970902802926.
PubMed 19555209Mickey DD, Bencuya PS, Foulkes K. Effects of the immunomodulator PSK on growth of human prostate adenocarcinoma in immunodeficient mice. Int J Immunopharmacol. 1989;11(7):829-38. doi: 10.1016/0192-0561(89)90137-9.
PubMed 2599718Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.
PubMed 7910230Oba K, Teramukai S, Kobayashi M, Matsui T, Kodera Y, Sakamoto J. Efficacy of adjuvant immunochemotherapy with polysaccharide K for patients with curative resections of gastric cancer. Cancer Immunol Immunother. 2007 Jun;56(6):905-11. doi: 10.1007/s00262-006-0248-1. Epub 2006 Nov 15.
PubMed 17106715Odabasi Z, Mattiuzzi G, Estey E, Kantarjian H, Saeki F, Ridge RJ, Ketchum PA, Finkelman MA, Rex JH, Ostrosky-Zeichner L. Beta-D-glucan as a diagnostic adjunct for invasive fungal infections: validation, cutoff development, and performance in patients with acute myelogenous leukemia and myelodysplastic syndrome. Clin Infect Dis. 2004 Jul 15;39(2):199-205. doi: 10.1086/421944. Epub 2004 Jun 28.
PubMed 15307029Ostrosky-Zeichner L, Alexander BD, Kett DH, Vazquez J, Pappas PG, Saeki F, Ketchum PA, Wingard J, Schiff R, Tamura H, Finkelman MA, Rex JH. Multicenter clinical evaluation of the (1-->3) beta-D-glucan assay as an aid to diagnosis of fungal infections in humans. Clin Infect Dis. 2005 Sep 1;41(5):654-9. doi: 10.1086/432470. Epub 2005 Jul 21.
PubMed 16080087
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01685489
- Acronym / sponsor ID
- 1U19AT006028-01A1
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate, Neoplasm, Adenocarcinoma, Cancer, Metastatic, Castrate resistant, Docetaxel, PSK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding sequestered
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Collaborators
- University of Washington, Fred Hutchinson Cancer Center
- Study start
- May 2013
- First posted
- 14 Sep 2012 (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 is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4 (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of PSK/placebo lead-in and during cycles 1 and 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel, PSK® | Experimental | Drug: Docetaxel, PSK®A 21-day lead-in oral PSK alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 evey 3 weeks for three cycles. After the third dose of docetaxel, study drug will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered. |
| Docetaxel, Placebo | Placebo comparator | Drug: Docetaxel, PlaceboA 21-day lead-in oral placebo alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. After the third dose of docetaxel, the placebo will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male patients 18 years or older
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Evidence of metastatic disease by standard imaging studies (bone scan, Computerized Tomography Scan (CT) or Magnetic Resonance Imaging (MRI))
- Testosterone levels <50 ng/dL
- Confirmed progressive disease defined by one or more of the following:
Key exclusion criteria (19 listed)
- Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic disease
- Prior adjuvant or neo-adjuvant chemotherapy within 12 months of study entry
- Last dose of sipuleucel-T therapy within 4 weeks of enrollment
- Any investigational therapies within 4 weeks of study entry
- Radiotherapy within 4 weeks of study entry
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 |
|---|---|---|
| Docetaxel, PSK®Also: Polysaccharide-K, Krestin, Polysaccharide-Kureha | Drug | Docetaxel, PSK® |
| Docetaxel, Placebo | Drug | Docetaxel, Placebo |
Primary outcome
Determine tolerability dose of PSK alone and in combination with docetaxel
Time frame: 42 days
Adverse events are graded to determine a dose limiting toxicity of PSK during the lead-in PSK alone and during the docetaxel treatment in combination with PSK.
Determine maximum tolerated dose and recommended phase 2 dose of PSK in combination with docetaxel
Time frame: 106 days
When the maximum tolerated dose is determined, a total of 15 patients will be treated with the recommended phase 2 dose with the combination of docetaxel chemotherapy.
5 secondary outcomes
Pharmacokinetics of docetaxel when combined with oral PSK
Time frame: 106 days
Pharmacokinetics of oral PSK dosing and in combination with docetaxel
Time frame: 106 days
Immunological laboratory analysis
Time frame: 106 days
Clinical tumor markers
Time frame: 106 days
Prostatic acid phosphatase
Time frame: 106
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 Oct 2015.
- Background: PubMed 20179598Antonarakis ES, Drake CG. Current status of immunological therapies for prostate cancer. Curr Opin Urol. 2010 May;20(3):241-6. doi: 10.1097/MOU.0b013e3283381793.
- Background: PubMed 18829513de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008 Oct 1;14(19):6302-9. doi: 10.1158/1078-0432.CCR-08-0872.
- Background: PubMed 12168863Fisher M, Yang LX. Anticancer effects and mechanisms of polysaccharide-K (PSK): implications of cancer immunotherapy. Anticancer Res. 2002 May-Jun;22(3):1737-54.
- Background: PubMed 20353536Fizazi K, Sternberg CN, Fitzpatrick JM, Watson RW, Tabesh M. Role of targeted therapy in the treatment of advanced prostate cancer. BJU Int. 2010 Mar;105(6):748-67. doi: 10.1111/j.1464-410X.2010.09236.x.
- Background: PubMed 3139576Fujita H, Ogawa K, Ikuzawa M, Muto S, Matsuki M, Nakajima S, Shimamura M, Togawa M, Yoshikumi C, Kawai Y. Effect of PSK, a protein-bound polysaccharide from Coriolus versicolor, on drug-metabolizing enzymes in sarcoma-180 bearing and normal mice. Int J Immunopharmacol. 1988;10(4):445-50. doi: 10.1016/0192-0561(88)90132-4.
- Background: PubMed 17062686Hurria A, Fleming MT, Baker SD, Kelly WK, Cutchall K, Panageas K, Caravelli J, Yeung H, Kris MG, Gomez J, Miller VA, D'Andrea G, Scher HI, Norton L, Hudis C. Pharmacokinetics and toxicity of weekly docetaxel in older patients. Clin Cancer Res. 2006 Oct 15;12(20 Pt 1):6100-5. doi: 10.1158/1078-0432.CCR-06-0200.
- Background: PubMed 8669887Iino Y, Yokoe T, Maemura M, Horiguchi J, Takei H, Ohwada S, Morishita Y. Immunochemotherapies versus chemotherapy as adjuvant treatment after curative resection of operable breast cancer. Anticancer Res. 1995 Nov-Dec;15(6B):2907-11.
- Background: PubMed 3170055Ikuzawa M, Matsunaga K, Nishiyama S, Nakajima S, Kobayashi Y, Andoh T, Kobayashi A, Ohhara M, Ohmura Y, Wada T, et al. Fate and distribution of an antitumor protein-bound polysaccharide PSK (Krestin). Int J Immunopharmacol. 1988;10(4):415-23. doi: 10.1016/0192-0561(88)90128-2.
- Background: PubMed 21918170Lu H, Yang Y, Gad E, Inatsuka C, Wenner CA, Disis ML, Standish LJ. TLR2 agonist PSK activates human NK cells and enhances the antitumor effect of HER2-targeted monoclonal antibody therapy. Clin Cancer Res. 2011 Nov 1;17(21):6742-53. doi: 10.1158/1078-0432.CCR-11-1142. Epub 2011 Sep 14.
- Background: PubMed 19555209Makkouk A, Abdelnoor AM. The potential use of Toll-like receptor (TLR) agonists and antagonists as prophylactic and/or therapeutic agents. Immunopharmacol Immunotoxicol. 2009;31(3):331-8. doi: 10.1080/08923970902802926.
- Background: PubMed 2599718Mickey DD, Bencuya PS, Foulkes K. Effects of the immunomodulator PSK on growth of human prostate adenocarcinoma in immunodeficient mice. Int J Immunopharmacol. 1989;11(7):829-38. doi: 10.1016/0192-0561(89)90137-9.
- Background: PubMed 7910230Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.
- General information of Bastyr UniversityLink 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.
Celestia Higano, MD study director
Seattle Cancer Care Alliance - University of Washington
Cynthia A Wenner, Ph.D study director
Bastyr University
Leanna J Standish, PhD, ND, LAc principal investigator
Bastyr University
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 Docetaxel, PSK® in people with Prostatic Neoplasms, run by Bastyr University 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 24 inclusion and 19 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 Oct 2015. 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. 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 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 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?
Determine tolerability dose of PSK alone and in combination with docetaxel (time frame: 42 days). 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 NCT01685489, which also lists 21 linked publications.
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 Oct 2015.