Phase III study of HYPOfractionated RadioTherapy of intermediate risk localised Prostate Cancer

Conditions

Intermediate risk localised prostate cancer Cancer Malignant neoplasm of prostate

Jiaoxue He, Qingfeng Wang, Qiancheng Hu, Changlin Li

Frontiers in Oncology2023-01-131 citations

10.3389/fonc.2022.841356

A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy – The PROPER 1 trial

Adalsteinn Gunnlaugsson, Vilberg Jóhannesson, Elinore Wieslander, Eva Brun, Ulrika Bitzèn et al. (11 authors)

Clinical and Translational Radiation Oncology2022-07-057 citations

10.1016/j.ctro.2022.07.001

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial.

Fransson P, Nilsson P, Gunnlaugsson A, Beckman L, Tavelin B, Norman D, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Björnlinger K, Seke M, Agrup M, Zackrisson B, Kjellén E, Franzén L, Widmark A.

2021-01-11103 citations

10.1016/s1470-2045(20)30581-7

Study protocol of a randomised controlled trial of prostate radiotherapy in high-risk and node-positive disease comparing moderate and extreme hypofractionation (PRIME TRIAL)

Vedang Murthy, Indranil Mallick, Abhilash Gavarraju, Shwetabh Sinha, Rahul Krishnatry et al. (16 authors)

BMJ Open2020-02-0127 citations

10.1136/bmjopen-2019-034623

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial.

Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Björnlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellén E, Franzén L, Nilsson P.

2019-06-18601 citations

10.1016/s0140-6736(19)31131-6

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.

Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E, CHHiP Investigators.

2016-06-20916 citations

10.1016/s1470-2045(16)30102-4

Interventions

Treatment technique: The radiation treatment shall be given with external photon beam therapy with three-dimensional conformal radiotherapy (3D-CRT) and/or intensity modulated radiation therapy (IMRT)

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Men less than 75 years of age and, as judged by the doctor, a life expectancy of 10 years (except for cancer) at time of randomisation with performance status World Health Organization (WHO) grades 0 - 2 2. Patients with a histologically verified prostatic cancer 3. Patients with intermediate risk prostatic cancer of clinical category T1c - T3a with one or two of the following risk factors: 3.1. T3a or Gleason greater than 7 3.2. PSA greater than 10 according to the TNM classification system UICC 2002 4. PSA less than 20 µg/L 5. The patients should have no evidence of metastases according to the definition above 6. Patients should be lymph node negative according to the definition above, i.e. staging 7. Patients should be suitable for radiotherapy 8. Patients must have signed informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who earlier have undergone any other treatment for prostatic cancer 2. Patients unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment (e.g. colitis) 3. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour. 4. Previous hormone therapy (castration or anti-androgens) 5. Any condition that prevent markers implantation, i.e. anal fissure

Design outcomes

Primary

Measure	Time frame
Freedom from failure (PSA or any clinical), measured five years after the end of treatment.	—

Secondary

Measure	Time frame
1. PSA response rate 2. Time to symptoms related to local progression 3. Time to symptoms related to distant progression 4. Cancer specific survival 5. Overall survival 6. Quality of Life (QoL) and side effects with special focus on sexual function, urinary and gastrointestinal morbidity Measured five years after the end of treatment.	—

Countries

Sweden

Outcome results

None listed