University Health Network, Toronto
05/08/2022
01/08/2028
MEN
60
18
No
This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
- Men older than 18 years old.
- Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
- Previous radical prostatectomy.
- Biochemical relapse with local or regional recurrence proven on PSMA PET.
- Five or less positive nodes on the PSMA PET.
- ECOG 0-1
- Presence of para-aortic lymph nodes or distant metastasis.
- Chronic pelvic inflammatory disease.
- Contraindication for radiation treatment.
- Previous radiation treatment within the pelvis
| PARTICIPANT GROUP ARM | INTERVENTION TREATMENT |
|---|---|
| Experimental: Molecular Imaging Informed Radiation Dose Escalation and De-escalation Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas. | Radiation: Image-guided Radiotherapy de-escalation radiotherapy to elective volumes + simultaneous integrated boost to PSMA avid lesions delivered in 20 fractions +/- ADT (clinical decision). The elective prostate bed and pelvic lymph node regions will receive 45 Gy. The PSMA-avid lymph node(s) will receive an SIB to 55-60 Gy and/or the PSMA-avid lesion in the prostate bed will receive an SIB to 60 Gy. Pelvic nodal treatment and ADT use will be left to the discretion of the treating physician. |
| Measures | Measure Description | MEASURE TIME FRAME |
|---|---|---|
| Grade ≥2 Toxicity for GU | Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Baseline to 5-year follow-up |
| MEASURES | MEASURE DESCRIPTION | MEASURE TIME FRAME |
|---|---|---|
| Biochemical Failure Free Survival | Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels | Baseline to 5-year follow-up |
| Patient-reported quality-of-life assessed by EPIC-26 | Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26) | Baseline to 5-year follow-up |