scholarly journals Modified Citrus Pectin Treatment in Non-Metastatic Biochemically Relapsed Prostate Cancer: Results of a Prospective Phase II Study

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4295
Author(s):  
Daniel Keizman ◽  
Moshe Frenkel ◽  
Avivit Peer ◽  
Igal Kushnir ◽  
Eli Rosenbaum ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Local Treatment ◽  
Outcome Analysis ◽  
Citrus Pectin ◽  
Cancer Pathogenesis ◽  
Prospective Phase ◽  
Psa Progression ◽  
Radiologic Progression

Optimal therapy of biochemically relapsed prostate cancer (BRPC) after local treatment is elusive. An established modified citrus pectin (PectaSol®, P-MCP), a dietary polysaccharide, is an established antagonist of galectin-3, a carbohydrate-binding protein involved in cancer pathogenesis. Based on PSA dynamics, we report on the safety and the primary outcome analysis of a prospective phase II study of P-MCP in non-metastatic BRPC based. Sixty patients were enrolled, and one patient withdrew after a month. Patients (n = 59) were given P-MCP, 4.8 grams X 3/day, for six months. The primary endpoint was the rate without PSA progression and improved PSA doubling time (PSADT). Secondary endpoints were the rate without radiologic progression and toxicity. Patients that did not progress by PSA and radiologically at six months continued for an additional twelve months. After six months, 78% (n = 46) responded to therapy, with a decreased/stable PSA in 58% (n = 34), or improvement of PSADT in 75% (n = 44), and with negative scans, and entered the second twelve months treatment phase. Median PSADT improved significantly (p = 0.003). Disease progression during the first 6 months was noted in only 22% (n = 13), with PSA progression in 17% (n = 10), and PSA and radiologic progression in 5% (n = 3). No patients developed grade 3 or 4 toxicity.

scholarly journals Patient-reported quality of life after salvage brachytherapy for radio-recurrent prostate cancer: A prospective Phase II study

Brachytherapy ◽  
2009 ◽  
Vol 8 (4) ◽  
pp. 345-352 ◽  
Author(s):  
Paul L. Nguyen ◽  
Ronald C. Chen ◽  
Jack A. Clark ◽  
Robert A. Cormack ◽  
Marian Loffredo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Recurrent Prostate Cancer ◽  
Patient Reported ◽  
Salvage Brachytherapy ◽  
Prospective Phase

Carbon ion radiation therapy for prostate cancer: Results of a prospective phase II study

2006 ◽  
Vol 81 (1) ◽  
pp. 57-64 ◽  
Author(s):  
Hitoshi Ishikawa ◽  
Hiroshi Tsuji ◽  
Tadashi Kamada ◽  
Takeshi Yanagi ◽  
Jun-Etsu Mizoe ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Carbon Ion ◽  
Prospective Phase

Multicenter Randomized Phase II Study of Two Schedules of Docetaxel, Estramustine, and Prednisone Versus Mitoxantrone Plus Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

2005 ◽  
Vol 23 (15) ◽  
pp. 3343-3351 ◽  
Author(s):  
Stéphane Oudard ◽  
Eugeniu Banu ◽  
Philippe Beuzeboc ◽  
Eric Voog ◽  
Louis Marie Dourthe ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Specific Antigen ◽  
Hormone Refractory Prostate Cancer ◽  
Randomized Phase Ii ◽  
Psa Response ◽  
Psa Progression ◽  
Hormone Refractory ◽  
To Receive

Purpose Mitoxantrone-corticosteroid is currently the standard palliative treatment in hormone-refractory prostate cancer (HRPC) patients. Recent clinical trials documented the high activity of the docetaxel-estramustine combination. We conducted a randomized phase II study to evaluate prostate-specific antigen (PSA) response (primary end point) and safety of two docetaxel-estramustine-prednisone (DEP) regimens and mitoxantrone-prednisone (MP). Patients and Methods One hundred thirty metastatic HRPC patients were randomly assigned to receive docetaxel (70 mg/m2 on day 2 or 35 mg/m2 on days 2 and 9 of each 21-day cycle) and estramustine (280 mg PO tid on days 1 through 5 and 8 through 12) or mitoxantrone 12 mg/m2 every 3 weeks; all patients received prednisone (10 mg daily). Results One hundred twenty-seven patients were assessable for PSA response and safety. A ≥ 50% PSA decline was found in a greater percentage of patients in the docetaxel arms (67% and 63%) compared with MP (18%; P = .0001). Median time to PSA progression was five times longer with DEP than with MP (8.8 and 9.3 v 1.7 months, respectively; P = .000001). Overall survival was better in the docetaxel arms (18.6 and 18.4 months) compared with the MP arm (13.4 months), but not significantly so (P = .3). Crossover rates differed significantly among treatment arms (16%, 10%, and 48% in arms A, B, and C, respectively; P = .00001). Treatment-related toxicities were mild and mainly hematologic. Conclusion The results of this randomized phase II study showed significantly higher PSA decline ≤ 50% and longer times to progression in HRPC patients receiving DEP-based chemotherapy than MP, and that DEP could be proposed in this setting.

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