Prostate Cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Phase II aims to determine whether moderately fractionated extended field intensity modulated radiotherapy (IMRT) is safe in node positive prostate cancer. In the Phase III PEARLS aims to determine wh
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old). 2. Any T stage, N1, M0; any T stage, N1, M1a (limited to para-aortic region); or any T stage, N0, M1a (limited to para-aortic region) on PSMA PET-CT imaging done at time of diagnostic staging (stage IV disease). 3. Age at least 18 years. 4. Patient on LHRH analogue therapy. 5. Adequate renal and bone marrow function. 6. WHO Performance status of 0-2. 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to the prostate or pelvis; prior bilateral orchiectomy; radical prostatectomy. 2. For those patients who have received docetaxel chemotherapy or are receiving androgen receptor targeted therapy, there should be no ongoing CTCAE grade 2 or greater GI toxicity relating to this systemic therapy. 3. Medical conditions (non-prostate cancer related) expected to limit life expectancy to < 5 years. 4. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult. 5. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, intractable urinary symptoms, previous colorectal surgery. 6. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin or small renal masses under surveillance), or if previous malignancy is expected to significantly compromise 5 year survival. 7. Any other contraindication to external beam radiotherapy to the para-aortic and/or pelvic region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Acute lower gastrointestinal (GI) toxicity at week 18 from the start of radiotherapy measured using Radiation Oncology/Toxicity grading (RTOG) Phase III: Metastasis-free survival (MFS) defined as the time from randomisation to the first detection of distant metastasis on imaging or death from any cause, whichever occurs first, measured using patient records. Distant metastasis defined as extra-pelvic lymphadenopathy, bone and visceral metastases | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II 1. Toxicity will be measured at the following time points: 18 week, 6, 12, 18, 24 months and then annually for 5 years (excluding FBC after 24 months) using RTOG, CTCAE v5 GI, genitourinary (GU), blood/bone marrow (FBC) 2. Ability to deliver 44Gy in 20 fractions to the pelvic and para-aortic lymph nodes with an integrated boost to the involved lymph nodes of 51Gy in 20 fractions within organ at risk dose constraints using the varying radiotherapy planning techniques and delivery systems at participating centres 3. Patient Reported Outcomes at end of radiotherapy and week 18 follow up: 3.1. Prostate cancer related quality of life (EPIC-26) 3.2. Prostate symptoms (IPSS) 3.3. Symptomatic toxicity (PRO-CTCAE) 3.4. Quality of life (EQ-5D-5L) 4. Late RTOG and CTCAE v5 GI, GU at 6, 12, 18 and 24 months Phase III 5. Acute toxicity RTOG, CTCAE v5 GI, genitourinary (GU), blood/bone marrow (FBC) up to 18 week follow-up 6. Late RTOG and CTCAE v5 GI, GU, blood/bone marrow (FBC) toxicity at 6, 12, 18 and 24 months and then annually for 5 years (excluding blood/bone marrow (FBC) toxicity from 24 months) 7. Patient-Reported Outcomes at end of radiotherapy, week 18, month 6, 12, 18, 24 and 60: 7.1. Prostate cancer related quality of life (EPIC-26) 7.2. Prostate symptoms (IPSS) 7.3. Symptomatic toxicity (PRO-CTCAE) 7.4. Quality of life (EQ-5D-5L) 8. Time to biochemical progression defined as time (in days) from randomisation to 1st biochemical progression (Phoenix definition: 2ng/ml increase in PSA over the nadir achieved after completion of radiotherapy treatment) measured using patient records 9. Time to radiographic progression defined as time (in days) from randomisation to radiographic progression measured using patient records 10. Failure-free survival defined as the time (in days) from randomisation to first biochemical failure, recommencement of androgen deprivation therapy, local recurrence, lymph node/pelvic recurrence, distant metastases or death due to prostate | — |
Countries
England, United Kingdom
Outcome results
None listed