Long-term Follow-up of a Prospective Phase I-II Study of Concurrent Paclitaxel and Radiation Therapy With Hormonal Ablation in Locally Advanced Prostate Cancer

IntroductionPatients with locally advanced prostate cancer are at high risk of recurrence after definitive treatment. There are emerging data that radical prostatectomy can delay the progression of castration resistance and potentially prolong survival. Neoadjuvant radiation therapy improves local control and has shown survival benefit with favourable toxicity profiles in several other malignancies. We have designed this trial to investigate whether this combination, which theoretically maximises local control, is a safe and feasible approach for treating locally advanced prostate cancer.Methods and analysisThis study is a phase I, open-label study to investigate the safety and feasibility of neoadjuvant hormone and radiation therapy followed by robot-assisted radical prostatectomy by a traditional 3+3 dose-escalation design with four planned radiation dose levels (39.6 Gy/22F, 45 Gy/25F, 50.4 Gy/28F and 54 Gy/30F). Locally advanced prostate cancer patients with positive pelvic and/or retroperitoneal lymph nodes will be recruited. The primary objective is to determine the adverse events and maximal tolerable dose (MTD) of neoadjuvant radiotherapy. Toxicity will be assessed using the National Cancer Institute Common Toxicity Criteria V.5.0.Ethics and disseminationThis protocol was approved by the Institutional Review Board of Shanghai Changhai Hospital (ref. CHEC2019-070 and CHEC2019-082). The study will be performed in compliance with applicable local legislation and in accordance with the ethical principles developed by the World Medical Association in the Declaration of Helsinki 2013. Study results will be disseminated through conferences and peer-reviewed scientific journals.Trial registration numbersChiCTR1900022716; ChiCTR1900022754.

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Preliminary phase I data on the feasibility of administering twice-a-week paclitaxel and definitive radiation therapy for androgen-ablated locally advanced prostate cancer

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/s0360-3016(01)02378-1 ◽

2001 ◽

Vol 51 (3) ◽

pp. 301-302

Author(s):

B.E. Ellerin ◽

A. Chachoua ◽

S. Taneja ◽

M. Saboori ◽

K. DeWyngaert ◽

...

Keyword(s):

Prostate Cancer ◽

Radiation Therapy ◽

Phase I ◽

Advanced Prostate Cancer ◽

Locally Advanced ◽

Locally Advanced Prostate Cancer ◽

Preliminary Phase

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Ten-Year Follow-Up of Radiation Therapy Oncology Group Protocol 92-02: A Phase III Trial of the Duration of Elective Androgen Deprivation in Locally Advanced Prostate Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2007.14.9021 ◽

2008 ◽

Vol 26 (15) ◽

pp. 2497-2504 ◽

Cited By ~ 478

Author(s):

Eric M. Horwitz ◽

Kyounghwa Bae ◽

Gerald E. Hanks ◽

Arthur Porter ◽

David J. Grignon ◽

...

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Radiation Therapy ◽

Gleason Score ◽

Advanced Prostate Cancer ◽

Locally Advanced ◽

Androgen Deprivation ◽

Locally Advanced Prostate Cancer ◽

End Points

PurposeTo determine whether adding 2 years of androgen-deprivation therapy (ADT) improved outcome for patients electively treated with ADT before and during radiation therapy (RT).Patients and MethodsProstate cancer patients with T2c-T4 prostate cancer with no extra pelvic lymph node involvement and prostate-specific antigen (PSA) less than 150 ng/mL were included. All patients received 4 months of goserelin and flutamide before and during RT. They were randomized to no further ADT (short-term ADT [STAD] + RT) or 24 months of goserelin (long-term ADT [LTAD] + RT). A total of 1,554 patients were entered. RT was 45 Gy to the pelvic nodes and 65 to 70 Gy to the prostate. Median follow-up of all survival patients is 11.31 and 11.27 years for the two arms.ResultsAt 10 years, the LTAD + RT group showed significant improvement over the STAD + RT group for all end points except overall survival: disease-free survival (13.2% v 22.5%; P < .0001), disease-specific survival (83.9% v 88.7%; P = .0042), local progression (22.2% v 12.3%; P < .0001), distant metastasis (22.8% v 14.8%; P < .0001), biochemical failure (68.1% v 51.9%; P ≤ .0001), and overall survival (51.6% v 53.9%, P = .36). One subgroup analyzed consisted of all cancers with a Gleason score of 8 to 10 cancers. An overall survival difference was observed (31.9% v 45.1%; P = .0061), as well as in all other end points herein.ConclusionLTAD as delivered in this study for the treatment of locally advanced prostate cancer is superior to STAD for all end points except survival. A survival advantage for LTAD + RT in the treatment of locally advanced tumors with a Gleason score of 8 to 10 suggests that this should be the standard of treatment for these high-risk patients.

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