Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial

93 Background: Oligorecurrent pelvic nodal relapse of prostatic cancer is a challenge for regional salvage treatments. We conducted OLIGOPELVIS – GETUG P07, a phase II trial of combined salvage radiotherapy and hormone therapy in oligorecurrent pelvic node relapses of prostate cancer (NCT02274779). Methods: OLIGOPELVIS–GETUG P07 was a prospective multi-center phase II trial investigating high-dose salvage pelvic irradiation with an additional dose to the fluorocholine-based positron-emission-tomography (FCH- PET)-positive pelvic lymph nodes (PLN), combined with six-month androgen blockade (LH-RH agonist or antagonist injections). The prescribed dose was 54 Gy in 1.8 Gy fractions with up to 66 Gy in 2.2 Gy fractions to the pathological PLN. Toxicity (CTCAE v4) and complete response rates (PSA < 0.20 ng/ml) were analyzed. The main objective was to assess biochemical-clinical failure defined by a cluster of events including PSA progression (≥25 % and ≥ 2 ng/ml above the nadir) or clinical evidence of local or metastatic progression or post- treatment initiation of hormonal therapy or prostate cancer-related death. We hypothesized that salvage treatment would achieve a 2-year relapse-free survival of 70 %. Results: Seventy-four patients were recruited in fifteen French radiation oncology departments between August 2014 and July 2016. Seven were excluded before treatment because of violation of the inclusion criteria. The intention-to-treat analysis therefore included sixty-seven patients. Half of them had received prior prostatic/prostate bed irradiation. Median age was 67.7. Grade 2+ two-year urinary and intestinal toxicity were 10% and 2% respectively. At 2 and 3 years, 73.1 and 45.9% of patients achieved a persisting complete response respectively. After a median follow-up of 34 months, the 2-year progression-free survival rate was 77.6%. Median progression-free survival was 40.1 months. Conclusions: Combined pelvic salvage radiotherapy and hormone therapy allowed for prolonged tumor control in oligorecurrent pelvic node relapses of prostate cancer with limited toxicity. Clinical trial information: NCT02274779.

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Metronomic cyclophosphamide therapy in hormone-naive patients with non-metastatic biochemical recurrent prostate cancer: a phase II trial

Medical Oncology ◽

10.1007/s12032-016-0806-0 ◽

2016 ◽

Vol 33 (8) ◽

Cited By ~ 4

Author(s):

Fabien Calcagno ◽

Guillaume Mouillet ◽

Olivier Adotevi ◽

Tristan Maurina ◽

Thierry Nguyen ◽

...

Keyword(s):

Prostate Cancer ◽

Phase Ii ◽

Phase Ii Trial ◽

Recurrent Prostate Cancer ◽

Cyclophosphamide Therapy ◽

Metronomic Cyclophosphamide

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Phase II Trial of Enzalutamide and Androgen Deprivation Therapy with Salvage Radiation in Men with High-risk Prostate-specific Antigen Recurrent Prostate Cancer: The STREAM Trial

European Urology Oncology ◽

10.1016/j.euo.2020.01.005 ◽

2020 ◽

Cited By ~ 1

Author(s):

Rhonda L. Bitting ◽

Patrick Healy ◽

Daniel J. George ◽

Monika Anand ◽

Sung Kim ◽

...

Keyword(s):

Prostate Cancer ◽

High Risk ◽

Prostate Specific Antigen ◽

Androgen Deprivation Therapy ◽

Phase Ii ◽

Phase Ii Trial ◽

Specific Antigen ◽

Androgen Deprivation ◽

Recurrent Prostate Cancer

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A phase I trial of muscadine grape skin in men with biochemically recurrent prostate cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.4_suppl.263 ◽

2014 ◽

Vol 32 (4_suppl) ◽

pp. 263-263

Author(s):

Channing Judith Paller ◽

Michelle A. Rudek ◽

Emmanuel S. Antonarakis ◽

Mario A. Eisenberger ◽

Hans J. Hammers ◽

...

Keyword(s):

Prostate Cancer ◽

Phase I ◽

Phase Ii ◽

Phase Ii Trial ◽

High Dose ◽

Recurrent Prostate Cancer ◽

Grape Skin ◽

Study Results ◽

Patient Reported ◽

Muscadine Grape

263 Background: New therapies are being explored as an alternative to observation in men with biochemically recurrent prostate cancer (BRPC). Muscadine Grape Skin (MPX) is comprised of ellagic acid, quercetin, and resveratrol and demonstrates preclinical activity against prostate cancer cells in vitro. Here we summarize data from a phase I dose finding trial. Methods: This phase I study assigned non-metastatic BRPC patients to increasing doses of MPX (Muscadine Naturals) in cohorts of two patients, with six patients at the highest dose, using a modified continual reassessment method. Dose selection is based on preclinical data showing the equivalent of 500 to 4,000 mg of MPX to be safe in mouse models. Our primary end point was to determine the recommended phase II dosing. We calculated changes in prostate-specific antigen (PSA) doubling time (PSADT) from at least three measurements prior to trial initiation and PSA measurements on study. Results: The cohort (n=14, 71% white, 29% black) had a median follow-up of 14.7 (6.9 to 20.7) months, median age 61, median Gleason seven, and median PSA of 5.1 ng/mL (0.2 to 153.4). Four patients had possibly related gastrointestinal symptoms, including grade 1 flatulence, grade 1 soft stools, and grade 1 burping. No other related adverse events were reported and one patient reported improvement of chronic constipation. Two of 14 patients came off study for metastatic disease. Median within-patient PSADT increased from 9.4 to 12.3 months with a PSADT difference of 3.9 months. Conclusions: These data suggest that 4,000 mg of MPX is safe, and exploratory review of change in PSADT suggests there is enough data to proceed to a phase II trial. Both low dose (500 mg) and high dose (4,000 mg) MPX are being further investigated in a multicenter, placebo-controlled, dose evaluating phase II trial. Clinical trial information: NCT01317199.

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