Biochemical Recurrence of Malignant Neoplasm of Prostate, Neoplasm Recurrence, Local, Prostate Cancer, Prostate Cancer (Post Prostatectomy), Prostatic Neoplasms, Reccurent/Metastatic Solid Tumor Disease
Conditions
Keywords
Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Radiotherapy, High-Dose Hypofractionated, Pelvic Radiotherapy, Androgen Deprivation Therapy, Randomized Controlled Trials, Noninferiority Trials, Quality of Life, Treatment Outcome, Gastrointestinal Diseases / chemically induced, Urinary Tract Diseases / chemically induced, Radiation Injuries
Brief summary
Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule. Why is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe. What is being compared? Standard treatment (Arm A): 25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy Shorter treatment (Arm B): 20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy Both groups may also receive hormone therapy (ADT) for 6-24 months. Main Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar. Other Things to be Measured Cancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires) Who can join? Men who: Had prostate surgery Have a detectable PSA (≥0.2 ng/mL) No distant metastasis Are in good general health (ECOG 0-2) How long will the study last? About 12 years total: 2 years to enroll patients 10 years of follow-up
Interventions
RADIATIONStandard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)
Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques. Dose and Schedule: Prostate bed: 62.5 Gy in 25 fractions Pelvis: 45 Gy in 25 fractions Duration: Approximately 5 weeks
RADIATIONHypofractionated Post-Operative Salvage Radiotherapy (20 fractions)
Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques. Dose and Schedule: Prostate bed: 52.5 Gy in 20 fractions Pelvis: 43 Gy in 20 fractions Duration: Approximately 4 weeks
DRUGAndrogen Deprivation Therapy (ADT)
Type: Drug Description: Hormonal therapy with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin) ± short-term anti-androgen. Duration: 6 to 24 months, at physician's discretion. Additional Notes: Patients with pelvic nodal disease may receive abiraterone and prednisone for 24 months as per STAMPEDE protocol.
Sponsors
CHU de Quebec-Universite Laval
TerSera Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed prostate adenocarcinoma. * Prior radical prostatectomy with detectable PSA (≥0.2 ng/mL). * No evidence of distant metastasis (confirmed via bone scan and CT/MRI or TEP-PSMA if PSA is above 0.5 ng /ml). * Patient with Nodal recurrence within the pelvis are eligible * ECOG performance status 0-2. * Age ≥ 18 years. * Adequate baseline renal, hepatic, and hematologic function.
Exclusion criteria
* Prior pelvic radiotherapy. * Macroscopic local relapse on imaging * Presence of metastatic disease. * Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity. * Uncontrolled comorbidities affecting study participation. * Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity | Within 24 months after completion of radiotherapy. | The proportion of patients experiencing Grade 2 or higher GU or GI adverse events, assessed according to CTCAE v5.0 criteria, following post-operative salvage radiotherapy. This outcome measures treatment-related toxicity in both study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years. | IPSS is an 8-question tool evaluating Lower Urinary Tract Symptoms in prostate cancer and benign prostatic hyperplasia. Scores of 0-7 are mild, 8-19 moderate, and 20-35 severe. It measures frequency, urgency, straining, and nocturia, aiding treatment monitoring. |
| Functional Assessment of Cancer Therapy - Prostate (FACT-P) | Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years. | The FACT-P is a 39-item validated instrument used to evaluate Health-Related Quality of Life (HRQoL) specifically in prostate cancer patients. Each item is rated on a 5-point Likert scale (0 to 4). The total score ranges from 0 to 156, where a higher score indicates a better quality of life. |
| Biochemical Progression-Free Survival (bPFS) | Up to 10 years post-treatment. | Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising. |
| Progression-Free Survival (PFS) | Up to 10 years post-treatment. | Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first. |
| Metastasis-Free Survival (MFS) | Up to 10 years post-treatment. | Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause. |
| Time to Initiation of Systemic Salvage Therapy | Up to 10 years post-treatment. | Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy). |
| Expanded Prostate Cancer Index Composite-26 (EPIC-26) | Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years. | EPIC-26 is a validated 26-item, patient-reported questionnaire used to evaluate health-related quality of life, specifically urinary, bowel, sexual, and hormonal symptoms, following prostate cancer treatment. Responses are converted to a 0-100 scale. A higher score indicates better function or less bother. |
| Overall Survival (OS) | Up to 10 years post-treatment. | Time from the end of radiotherapy to death from any cause. |
Countries
Canada
Contacts
CONTACTEric Vigneault, MD, MSc
CONTACTDamien Carignan, PhD
PRINCIPAL_INVESTIGATOREric Vigneault, MD, MSc
CHU de Québec-Université Laval
Outcome results
None listed