STUNNIN: Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
Study Details
Study Description
Brief Summary
This is a prospective, open, randomized phase II trial.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: arm 1 SBRT alone 38 GY in 4 fractions |
|
Experimental: arm 2 SBRT along with short course (6 months) androgen deprivation (STAD) |
Drug: Decapeptyl
STAD androgen deprivation
Other Names:
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Outcome Measures
Primary Outcome Measures
- 3-yr bNED survival [3 years]
The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically proven prostate adenocarcinoma
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IR or HR in the NCCN definition
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N0M0 at staging with choline or (preferably) PSMA PET-CT;
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ECOG performance status between 0 and 2;
Exclusion Criteria:
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Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
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Previous radiotherapy to the pelvis
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Previous chemotherapy for malignancy in past 5 years
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Impossibility to implant fiducials for tracking purposes
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Impossibility to undergo MRI of the prostate
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Contraindication to short term AD
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Prostate volume >90cc
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ifo Regina elena | Rome | Lazio | Italy | 00144 |
2 | ifo Regina Elena | Rome | RM | Italy | 00144 |
3 | Regina Elena National Cancer Institute | Rome | Italy | 00144 |
Sponsors and Collaborators
- Regina Elena Cancer Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RS1399/20(2384) PU