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Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery.

ConditionsReccurent/Metastatic Solid Tumor DiseaseProstate Cancer (Post Prostatectomy)Prostate CancerProstatic NeoplasmsNeoplasm Recurrence, LocalBiochemical Recurrence of Malignant Neoplasm of Prostate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCHU de Quebec-Universite Laval

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior pelvic radiotherapy.

Macroscopic local relapse on imaging

Presence of metastatic disease.

Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)

    Radiation

    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

  • Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)

    Radiation

    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

  • Androgen Deprivation Therapy (ADT)

    Drug

    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.

Treatment groups

434 Participants
are divided into 2 treatment groups
Group A: Arm AActive comparator 2 interventions
Group B: Arm BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity

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.

Time frame
Within 24 months after completion of radiotherapy.

Secondary outcomes

1

Biochemical Progression-Free Survival (bPFS)

Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising.

Time frame
Up to 10 years post-treatment.
2

Progression-Free Survival (PFS)

Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first.

Time frame
Up to 10 years post-treatment.
3

Metastasis-Free Survival (MFS)

Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause.

Time frame
Up to 10 years post-treatment.
4

Time to Initiation of Systemic Salvage Therapy

Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy).

Time frame
Up to 10 years post-treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHU de Quebec-Universite Laval

Lead sponsor

TerSera Therapeutics LLC

Collaborator

Source ClinicalTrials.gov
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